Solid TumoursPhase 1INVOKENCT06789172
A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors
A Phase 1 study testing OKN4395, Pembrolizumab and Fasting in people with Solid Tumours and Sarcoma, run by Epkin at 10 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab. The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours, Sarcoma, HNSCC
- What is being tested?
- OKN4395, Pembrolizumab and Fasting
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 23 Jan 2025to Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed disease, locally advanced or metastatic:
- For Phase 1a:
- Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.
- For Phase 1b:
- For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted
- Cohort 1: Sarcoma (fibrous sarcoma [myxofibrosarcoma or solitary fibrous tumor], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.
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- Cohort 2: NSCLC (squamous or adenomatous without EGFR/ALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.
- Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.
- Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy cessation.
- ECOG performance status of 0 or 1.
- Recovery from any medically relevant AE/irAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs [not worsened to Grade >2 for >3 months prior to screening]).
- One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year [Phase 1a], or within 90 days and after the last administration of the previous systemic therapy [Phase 1b] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).
- At least one target lesion measurable by RECIST 1.1 as noted by local investigators/radiologists.
- The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.
- The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition known to affect upper gastrointestinal motility, absorption, and pH.
- Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):
- Hematological variables: absolute neutrophil counts ≥1.5 × 109 /L, platelet counts ≥75 × 109 /L, and hemoglobin ≥8 g/dL
- Renal variables: creatinine clearance ≥ 60 mL/min1 by Du Bois \& Du Bois formula
- Hepatic variables: total serum bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, and ALP ≤2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin ≤5× ULN and direct bilirubin ≤1.5 x ULN)
- Serum albumin ≥30 g/L
Who cannot join
- Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:
- Chemotherapy, ADCs, or other antibodies < 21 days
- Immunotherapy or cellular therapy < 28 days
- Radiation therapy (palliative radiation for bone pain <48 hours; stereotactic or small field brain irradiation <7 days; all other radiation therapy <14 days)
- TKI or any other anticancer therapy < 5 half-lives or < 7 days, whichever is longer
- Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies [including low dose steroids]).
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- Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.
- Unstable COPD defined as frequent or severe exacerbations per investigator discretion.
- Known history of or active HBV (HBsAg reactive and/or HBV DNA detected) or HCV (HCV RNA detected) infection.
- HIV infection with CD4 lymphocyte count <350 cells/μL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level < 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening.
- Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and/or aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.
- Known H. pylori infection without proof of eradication at least 2 months prior to screening.
- Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for more than 2 weeks prior to discontinuation, discontinuation should occur at least 21 days before first dose of OKN4395.
- Acute treatment with any systemic steroid therapy (>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.
- For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.
- Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg/day, or 325 mg ≤ 3 times/week is permitted).
- Systemic treatment with strong inhibitors/inducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.
- QTcF interval of > 450 ms based on mean of the central triplicate readings.
- Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).
- Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).
- Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).
- History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
United Kingdom5 sites, 5 recruiting
- Recruiting
The Beatson
Glasgow
- Recruiting
Leicester Royal Infirmary
Leicester, LE1 5WW
- Recruiting
University College London Hospital
London
uclh.randd@nhs.net
- Recruiting
The Christie
Manchester
- Recruiting
Churchill Hospital
Oxford
United States3 sites, 3 recruiting
- Recruiting
Precision NextGen Oncology and Research Center
Beverly Hills, California, 90212
Sankhala, (424)777-0708
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Sarcoma Oncology Center
Santa Monica, California, 90403
Chawla, (310) 552-9999, vchua@sarcomaoncology.com
Australia2 sites, 2 recruiting
- Recruiting
Linear Clinical Research
Perth, Western Australia, 6009
+61 (08) 6382 5100, actc-management@linear.org.au
- Recruiting
Chris O'Brien Lifehouse
Sydney, New South Wales
About this study
Official title: A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors
The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.
The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.
Read more
This study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.
Part 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.
The overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.
The study will be conducted in the US, Australia, UK and in the EU.
- Conditions
- Solid Tumours, Sarcoma, HNSCC, Non Small Cell Lung Cancer, NSCLC, Colorectal Cancer (CRC)
- Being tested
- OKN4395, Pembrolizumab, Fasting, Fed, H2 Receptor Antagonist
- Medical subject headings
- Sarcoma, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Dermatofibrosarcoma, Solitary Fibrous Tumors, Liposarcoma, Histiocytoma, Malignant Fibrous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKN4395Drug
OKN4395 oral dosing twice per day
PembrolizumabCombination product
200 mg IV every 3 weeks
FastingOther
Fasting before first dose of OKN4395
FedOther
Food provided to patient before first OKN4395 dose
H2 Receptor AntagonistDrug
Also called Famotidine, H2RA
Famotidine 20 mg IV (as a slow push over 2 minutes) administered 3 hours prior to OKN4395
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation Phase (Phase 1a) | Experimental | The Monotherapy Escalation Phase will include increasing doses of OKN4395 alone in patients with solid tumors with a COX2-associated immunosuppressive pathway. Receives: Drug: OKN4395 |
| Combination Dose Confirmation Phase (Phase 1a) | Experimental | The Combination Dose Confirmation Phase will include increasing or decreasing doses of OKN4395 in combination with pembrolizumab in patients with solid tumors with a COX2-associated immunosuppressive pathway. The first dose level used will be 1 level below the identified OBD/MTD for monotherapy. Subsequent dose levels tested will either be increased or decreased in response to observed toxicity. Receives: Drug: OKN4395; Combination Product: Pembrolizumab |
| Phase 1a Substudy 1 | Experimental | Participants will receive 3 doses of OKN4395 in a fasted, fed, and high gastric pH state (once each) with a washout period inbetween. Each state and dose will occur within the first 8 days of treatment (C1 D1-D8). The sequence of these predose conditions will be randomized. After C1 D8, participants will receive OKN4395 as monotherapy twice per day, in line with the dose escalation portion of the study, for the remainder of treatment.
The high pH state is achieved through co-administration of the H2 receptor antagonist, famotidine, administered 2 hours before OKN4395 at a dose of 20mg intravenously. Receives: Drug: OKN4395; Other: Fasting; Other: Fed; Drug: H2 Receptor Antagonist |
| Phase 1b Cohort 1: Sarcoma | Experimental | OKN4395 (OBD/MTD monotherapy dose) Receives: Drug: OKN4395 |
| Phase 1b Cohort 2: Non-Small Cell Lung Cancer | Experimental | OKN4395 (OBD/MTD combination dose) in combination with pembrolizumab Receives: Drug: OKN4395; Combination Product: Pembrolizumab |
| Phase 1b Cohort 3: Colorectal Cancer | Experimental | OKN4395 (OBD/MTD combination dose) in combination with pembrolizumab Receives: Drug: OKN4395; Combination Product: Pembrolizumab |
| Phase 1b Cohort 4: Gastric Cancer | Experimental | OKN4395 (OBD/MTD combination dose) in combination with pembrolizumab Receives: Drug: OKN4395; Combination Product: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab. (Phase 1a)
DLTs = dose-limiting toxicities
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Incidence and severity of TEAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
TEAEs = treatment-emergent adverse events
Measured: From enrolment of the first participant to the end of Phase 1a; up to 27 months
Incidence and severity of SAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
SAEs = serious adverse events
Measured: From enrolment of the first participant to the end of Phase 1a; up to 27 months
Incidence of dose interruptions, dose reductions, and dose intensities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Measured: From enrolment of the first participant to the end of Phase 1a; up to 27 months
Incidence and severity of clinically relevant ECG abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
ECG = electrocardiogram
Measured: From enrolment of the first participant to the end of Phase 1a; up to 27 months
Incidence and severity of laboratory abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Graded where appropriate with the CTCAE v5.0.
Measured: From enrolment of the first participant to the end of Phase 1a; up to 27 months
Incidence and severity of clinically relevant changes in vital signs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Measured: From enrolment of the first participant to the end of Phase 1a; up to 27 months
To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b Cohorts 1-3)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the progression-free survival in participants treated with OKN4395 in combination with pembrolizumab in selected cancer types. (Phase 1b Cohort 4)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcomes (29)
To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the disease control rate at >=12 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the duration of response in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the progression-free survival in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the time to treatment failure in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the overall survival rate at 24 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To characterize the maximum plasma concentration (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To characterize the area under the curve (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To characterize the terminal half life (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To characterize the clearance (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To evaluate the effect of food and gastric pH on OKN4395 in order to permit less restrictive dosing. (Phase 1a Substudy 1)
Measured: From enrolment of the first participant in Substudy 1 until the end of Cycle 1 Day 8 of the last participant enrolled in Substudy 1
To assess the overall response rate in participants treated with OKN4395 in combination with pembrolizumab in selected cancer types. (Phase 1b Cohort 4)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the disease control rate at >=12 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the duration of response in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the progression-free survival in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the time to treatment failure in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the overall survival rate at 24 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of TEAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of SAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence of dose interruptions, dose reductions, and dose intensities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the maximum plasma concentration (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of clinically relevant ECG abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of laboratory abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of clinically relevant changes in vital signs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the area under the curve (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the terminal half life (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the clearance (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the accumulation index (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Measured: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the accumulation index (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Measured: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start23 Jan 2025
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epkin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Precision For Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789172
- Sponsor's protocol ID
- OKN-4395-121
- Acronym
- INVOKE
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stephane Champiat et al. Updated design of INVOKE: A phase 1 study of OKN4395, a first-in-class EP2/EP4/DP1 triple prostanoid receptor antagonist, in patients with advanced solid tumors.. J Clin Oncol 44, TPS2681-TPS2681(2026). DOI:10.1200/JCO.2026.44.16_suppl.TPS2681
Neal Shiv Chawla et al. INVOKE: A phase 1 study of OKN4395, a first-in-class EP2/EP4/DP1 triple prostanoid receptor antagonist, in patients with advanced solid tumors.. J Clin Oncol 43, TPS2683-TPS2683(2025). DOI:10.1200/JCO.2025.43.16_suppl.TPS2683
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06789172
- Acronym / sponsor ID
- INVOKE / OKN-4395-121
- Conditions
- Solid Tumours, Sarcoma, HNSCC, Non Small Cell Lung Cancer, NSCLC, Colorectal Cancer (CRC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- EpkinIndustry (pharma, biotech, devices)
- Collaborators
- Precision For Medicine
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.
The overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.
This study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.
Part 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.
The overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.
The study will be conducted in the US, Australia, UK and in the EU.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation Phase (Phase 1a) | Experimental | Drug: OKN4395The Monotherapy Escalation Phase will include increasing doses of OKN4395 alone in patients with solid tumors with a COX2-associated immunosuppressive pathway. |
| Combination Dose Confirmation Phase (Phase 1a) | Experimental | Drug: OKN4395, Combination Product: PembrolizumabThe Combination Dose Confirmation Phase will include increasing or decreasing doses of OKN4395 in combination with pembrolizumab in patients with solid tumors with a COX2-associated immunosuppressive pathway. The first dose level used will be 1 level below the identified OBD/MTD for monotherapy. Subsequent dose levels tested will either be increased or decreased in response to observed toxicity. |
| Phase 1a Substudy 1 | Experimental | Drug: OKN4395, Other: Fasting, Other: Fed, Drug: H2 Receptor AntagonistParticipants will receive 3 doses of OKN4395 in a fasted, fed, and high gastric pH state (once each) with a washout period inbetween. Each state and dose will occur within the first 8 days of treatment (C1 D1-D8). The sequence of these predose conditions will be randomized. After C1 D8, participants will receive OKN4395 as monotherapy twice per day, in line with the dose escalation portion of the study, for the remainder of treatment. The high pH state is achieved through co-administration of the H2 receptor antagonist, famotidine, administered 2 hours before OKN4395 at a dose of 20mg intravenously. |
| Phase 1b Cohort 1: Sarcoma | Experimental | Drug: OKN4395OKN4395 (OBD/MTD monotherapy dose) |
| Phase 1b Cohort 2: Non-Small Cell Lung Cancer | Experimental | Drug: OKN4395, Combination Product: PembrolizumabOKN4395 (OBD/MTD combination dose) in combination with pembrolizumab |
| Phase 1b Cohort 3: Colorectal Cancer | Experimental | Drug: OKN4395, Combination Product: PembrolizumabOKN4395 (OBD/MTD combination dose) in combination with pembrolizumab |
| Phase 1b Cohort 4: Gastric Cancer | Experimental | Drug: OKN4395, Combination Product: PembrolizumabOKN4395 (OBD/MTD combination dose) in combination with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically or cytologically confirmed disease, locally advanced or metastatic:
- Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.
- For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted
- ECOG performance status of 0 or 1.
- Recovery from any medically relevant AE/irAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs [not worsened to Grade >2 for >3 months prior to screening]).
Key exclusion criteria (22 listed)
- Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:
- Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies [including low dose steroids]).
- Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.
- Unstable COPD defined as frequent or severe exacerbations per investigator discretion.
- Known history of or active HBV (HBsAg reactive and/or HBV DNA detected) or HCV (HCV RNA detected) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKN4395OKN4395 oral dosing twice per day | Drug | Combination Dose Confirmation Phase (Phase 1a), Monotherapy Dose Escalation Phase (Phase 1a), Phase 1a Substudy 1, Phase 1b Cohort 1: Sarcoma, Phase 1b Cohort 2: Non-Small Cell Lung Cancer, Phase 1b Cohort 3: Colorectal Cancer, Phase 1b Cohort 4: Gastric Cancer |
| Pembrolizumab200 mg IV every 3 weeks | Combination product | Combination Dose Confirmation Phase (Phase 1a), Phase 1b Cohort 2: Non-Small Cell Lung Cancer, Phase 1b Cohort 3: Colorectal Cancer, Phase 1b Cohort 4: Gastric Cancer |
| FastingFasting before first dose of OKN4395 | Other | Phase 1a Substudy 1 |
| FedFood provided to patient before first OKN4395 dose | Other | Phase 1a Substudy 1 |
| H2 Receptor AntagonistAlso: Famotidine, H2RAFamotidine 20 mg IV (as a slow push over 2 minutes) administered 3 hours prior to OKN4395 | Drug | Phase 1a Substudy 1 |
Primary outcome
Incidence of DLTs in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
DLTs = dose-limiting toxicities
Incidence and severity of TEAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Time frame: From enrolment of the first participant to the end of Phase 1a; up to 27 months
TEAEs = treatment-emergent adverse events
Incidence and severity of SAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Time frame: From enrolment of the first participant to the end of Phase 1a; up to 27 months
SAEs = serious adverse events
Incidence of dose interruptions, dose reductions, and dose intensities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Time frame: From enrolment of the first participant to the end of Phase 1a; up to 27 months
Incidence and severity of clinically relevant ECG abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Time frame: From enrolment of the first participant to the end of Phase 1a; up to 27 months
ECG = electrocardiogram
Incidence and severity of laboratory abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Time frame: From enrolment of the first participant to the end of Phase 1a; up to 27 months
Graded where appropriate with the CTCAE v5.0.
Incidence and severity of clinically relevant changes in vital signs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Time frame: From enrolment of the first participant to the end of Phase 1a; up to 27 months
To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b Cohorts 1-3)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the progression-free survival in participants treated with OKN4395 in combination with pembrolizumab in selected cancer types. (Phase 1b Cohort 4)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
29 secondary outcomes
To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the disease control rate at >=12 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the duration of response in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the progression-free survival in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the time to treatment failure in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To assess the overall survival rate at 24 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To characterize the maximum plasma concentration (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To characterize the area under the curve (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To characterize the terminal half life (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To characterize the clearance (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
To evaluate the effect of food and gastric pH on OKN4395 in order to permit less restrictive dosing. (Phase 1a Substudy 1)
Time frame: From enrolment of the first participant in Substudy 1 until the end of Cycle 1 Day 8 of the last participant enrolled in Substudy 1
To assess the overall response rate in participants treated with OKN4395 in combination with pembrolizumab in selected cancer types. (Phase 1b Cohort 4)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the disease control rate at >=12 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the duration of response in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the progression-free survival in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the time to treatment failure in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To assess the overall survival rate at 24 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of TEAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of SAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence of dose interruptions, dose reductions, and dose intensities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the maximum plasma concentration (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of clinically relevant ECG abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of laboratory abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Incidence and severity of clinically relevant changes in vital signs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the area under the curve (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the terminal half life (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the clearance (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the accumulation index (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Time frame: From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
To characterize the accumulation index (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- BackgroundStephane Champiat et al. Updated design of INVOKE: A phase 1 study of OKN4395, a first-in-class EP2/EP4/DP1 triple prostanoid receptor antagonist, in patients with advanced solid tumors.. J Clin Oncol 44, TPS2681-TPS2681(2026). DOI:10.1200/JCO.2026.44.16_suppl.TPS2681
- BackgroundNeal Shiv Chawla et al. INVOKE: A phase 1 study of OKN4395, a first-in-class EP2/EP4/DP1 triple prostanoid receptor antagonist, in patients with advanced solid tumors.. J Clin Oncol 43, TPS2683-TPS2683(2025). DOI:10.1200/JCO.2025.43.16_suppl.TPS2683
- Information about the INVOKE trialLink provided by the sponsor.
- Information for participants in the INVOKE trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OKN4395, Pembrolizumab and Fasting in people with Solid Tumours and Sarcoma, run by Epkin at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Epkin (+33 787922617, clinicaltrials@owkin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLTs in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab. (Phase 1a) (time frame: From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06789172, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.