CancerPhase 1/2NCT05620134
Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer
A Phase 1/2 study testing JK08, Pembrolizumab and Lenvatinib Pill in people with Cancer and Tumor, Solid, run by Salubris Biotherapeutics Inc at 11 sites in 2 countries.
Trial summary
This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced or metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Tumor, Solid, Advanced Solid Tumor
- What is being tested?
- JK08, Pembrolizumab and Lenvatinib Pill
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 17 Oct 2022to 20 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years old.
- Signed informed consent and willing and able to comply with study procedures and scheduled visits.
- For Dose Escalation, patients with one of the following histologically diagnosed unresectable, locally advanced, or metastatic tumor types:
- Non-small cell lung cancer (NSCLC).
- Small cell lung cancer (SCLC).
- Melanoma.
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- Clear cell or papillary renal cell carcinoma (RCC).
- Urothelial cancer (UC).
- Head and neck squamous cell cancer (HNSCC).
- Luminal B (ER+, PR-, any HER2 status) or triple-negative breast cancer.
- Gastric or gastro esophageal adenocarcinoma (GC/GEJ).
- Esophageal squamous cell cancer.
- Skin squamous cell carcinoma (SCC).
- Pancreatic adenocarcinoma.
- Hepatocellular carcinoma (Childs-Pugh A or B7 only).
- Colorectal adenocarcinoma (CRC).
- Epithelial ovarian cancer.
- Cervical cancer.
- Endometrial adenocarcinoma.
- Thyroid cancer (follicular or papillary).
- Expansion Combination Cohorts
- Non-Small Cell Lung Cancer [limited to squamous and non-squamous carcinoma histology only]: (Combination with Pembrolizumab) patients must have received no more than 2 prior lines of therapy, including PD-(L)1 therapy and platinum-based chemotherapy. Patients must have been tested for relevant tumor mutations, translocation or other genomic aberrations for which an approved targeted therapy is available; if present, patients must have progressed on or be intolerant to mutation specific treatment.
- Colorectal Cancer: (Combination with Pembrolizumab) Patients must have disease burden outside of liver; i.e., absence of liver metastasis. Previously treated liver metastasis would be permitted. Patients must also have had recurrence, progression or intolerance to standard therapy consisting of at least 2 prior standard regimens (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease.
- Hepatocellular Cancer: (Combination with Lenvatinib) histologically confirmed adenocarcinoma diagnosis of advanced unresectable and/or metastatic HCC. Patients must have had only one prior line of therapy, which should be inclusive of anti-PD-(L)1 therapy and must have Childs Pugh A or B7.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Life expectancy ≥ 12 weeks.
- Measurable disease as per RECIST 1.1 criteria and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).
- Note: lesions treated previously with radiation must demonstrate clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrollment.
- Acceptable laboratory parameters:
- Albumin ≥ 2.8 g/dL.
- Platelet count ≥ 75,000.
- Hemoglobin ≥ 8.0 g/dL.
- Absolute neutrophil count ≥ 1,500/µL.
- ALT/AST ≤ 3.0 times ULN.
- ALT/AST ≤ 5 × ULN for patients with liver metastases.
- Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.
- Direct bilirubin ≤ ULN for patients with total bilirubin > 1.5 ULN.
- Creatinine ≤ 1.8 mg/dL.
- Or calculated/measured creatinine clearance > 30 mL/minute.
- Identification of an archival tumor sample (i.e., tissue block (formalin-fixed paraffin-embedded [FFPE]) or a series of approximately 10-15 slides).
- Consent to pre- and on- treatment fresh tumor biopsy for all patients enrolled as back fill in Dose Escalation or for at least 6 additional patients per expansion cohort in Cohort Expansion in Simon Stage 2. Note: Biopsies are not required for the Basket Cohort.
- Women of childbearing potential (WOCBP) not surgically sterilized and between menarche and 1 year post menopause must:
- Have a negative serum or urine pregnancy test performed within 72 hours prior to the initiation of study drug administration.
- Be willing to use 2 forms of effective contraception throughout the study, starting with the screening and through 90 days after the last dose of JK08.
- Abstinence is considered a highly effective method if this is the established and preferred contraception method for the patient and is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female and male condoms should not be used together.
- Male patients with partners of childbearing potential, even if surgically sterilized (i.e., status post-vasectomy) must agree to:
- Use effective barrier contraception from the time of consent through 90 days after discontinuation; or
- Agree to practice true abstinence, if this is the established and preferred contraception method by the patient and is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. Periodic abstinence [e.g., calendar, symptothermal, post-ovulation methods], withdrawal, spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female and male condoms should not be used together.
- In addition, male patients should also have their partners use contraception for the same period of time.
- Central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥14 days, and meet the following at the time of enrollment:
- No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids ≥ 10 mg prednisone/day or equivalent).
- No concurrent or past history of leptomeningeal disease or cord compression.
- Must be willing and able to comply with clinic visits and procedures outlined in the study protocol.
- Concurrent use of hormones for breast cancer or for non cancer related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates or RANK-L inhibitor or analogues are permitted for supportive care of patients with bone metastases.
Who cannot join
- Patients with symptomatic or unstable CNS primary tumor or metastases and/or carcinomatous meningitis. Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.
- Patients with active, or history of, severe autoimmune disease who in the opinion of the investigator and/or the Sponsor or Sponsor's designee would be exposed to unacceptable risk by participating in the study.
- Major surgery within 6 weeks from treatment initiation.
- Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose:
- Myocardial infarction or unstable angina.
- Clinically significant cardiac arrhythmias.
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- Uncontrolled hypertension: systolic blood pressure (SBP) > 180 mmHg, diastolic blood pressure (DBP) > 100 mmHg.
- Pulmonary embolism, symptomatic cerebrovascular events or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy).
- QTcF prolongation > 480 msec.
- Congestive heart failure (New York Heart Association class III-IV).
- Myocarditis/clinically significant pericarditis.
- Clinically significant gastrointestinal disorders including:
- Gastrointestinal perforation or unhealed ulcerations < 6 months prior to study drug administration. Patients must have documented evidence (e.g., upper endoscopy, colonoscopy) of completely healed area of prior perforation.
- Clinically significant gastrointestinal bleeding < 3 months prior to study drug administration.
- Pancreatitis < 6 months prior to study drug administration.
- History of Crohn's disease or ulcerative colitis.
- Clinically significant pulmonary compromise requiring supplemental oxygen use.
- History of Grade 3 or greater drug-related immune-mediated AE during treatment with CPIs such as anti-PD-(L)1 or anti-CTLA-4 antibodies.
- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. At least 2 doses of COVID-19 vaccination must have been completed prior to enrollment (see Section 8.2 for further details).
- Known hypersensitivity to JK08 or any excipient (histidine/histidine-HCl, sucrose, glycine, PS-80).
- Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non melanoma skin cancer, cervical carcinoma in situ, resected melanoma in situ, or any malignancy considered to be indolent and never required therapy.
- Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the patient to receive or tolerate the planned treatment.
- Recent or ongoing serious infection including the following:
- Any uncontrolled Grade 3 or higher (per CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of JK08. Routine antimicrobial prophylaxis is allowed.
- Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.
- Known to be positive for hepatitis B (HBV) surface antigen, or any other positive test for hepatitis B indicating acute or chronic infection. Patients who are or have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for hepatitis B at screening is not required.
- Known active hepatitis C (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or having received antiviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for hepatitis C at screening is not required.
- Known active or latent tuberculosis (testing at screening not required).
- Use of systemic corticosteroids within 15 days or other immunosuppressive drugs within 30 days prior to start of the study, with the exception of corticosteroids as replacement therapy up to an equivalent of prednisone 10 mg/day which is allowed. Inhaled, topical, or intraarticular steroids are allowed.
- Prior systemic anti-cancer treatment as follows:
- For cytotoxic chemotherapy, small molecule inhibitors, radiation, or similar investigational treatments, ≤ 2 weeks or 5 half lives, whichever is shorter.
- For monoclonal antibodies or similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter.
- Antibody drug conjugates and radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.
- Ascites or pleural effusions requiring large volume para- or pleurocentesis within 4 weeks of treatment initiation.
- Pregnant or nursing.
- Therapeutic anticoagulation for a thromboembolic event that occurred within 3 months of dosing; prophylactic anticoagulation is permitted.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Spain7 sites
NEXT Oncology Barcelona
Barcelona
Vall d Hebron Institute of Oncology VHIO
Barcelona
Next Oncology Madrid Hospital Quironsalud Madrid
Madrid
NEXT Oncology Madrid
Madrid
START Madrid
Madrid
University Hospital October 12
Madrid
Instituto de Investigación Sanitaria INCLIVA
Valencia
Belgium4 sites
Institut Jules Bordet
Brussels, 1070
UZA
Edegem
UZ Ghent
Ghent, 9000
CHU UCL Namur - site Godinne
Yvoir
About this study
Official title: A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, Monotherapy or in Combination in Patients with Unresectable Locally Advanced or Metastatic Cancer
This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced or metastatic cancer.
Read the detailed description
This Phase 1/2, open label, dose escalation and cohort expansion study is designed to evaluate and characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of JK08 administered subcutaneously (SC) on a once weekly (QW) schedule in patients with unresectable locally, advanced or metastatic cancer.
The study consists of a Dose Escalation phase to determine the MTD/OBD of JK08, followed by a Cohort Expansion phase to further define the safety and initial efficacy of JK08 monotherapy or in combinations.
- Conditions
- Cancer, Tumor, Solid, Advanced Solid Tumor, Metastatic Cancer, Melanoma, Colorectal Cancer
- Being tested
- JK08, Pembrolizumab, Lenvatinib Pill
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Melanoma, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoma, Transitional Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JK08Drug
Recombinant fusion protein consisting of two functional elements, which are a fully human monoclonal antibody, directed against CTLA-4 and a protein complex formed by the human IL-15 and the Sushi domain of human IL-15Rα.
PembrolizumabDrug
Immune checkpoint inhibitor
Lenvatinib PillDrug
Multi-kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Escalating repeated doses of JK08 administered as a subcutaneous injection. A cycle of treatment is defined as 21 days, in which three doses of JK08 will be planned for administration. Receives: Drug: JK08 |
| Dose Expansion Pembrolizumab Combination Cohort - Non-Small Cell Lung Cancer | Experimental | JK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Pembrolizumab will be given IV per standard institutional practice Receives: Drug: JK08; Drug: Pembrolizumab |
| Dose Expansion Pembrolizumab Combination Cohort - Colorectal Cancer | Experimental | JK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Pembrolizumab will be given IV per standard institutional practice Receives: Drug: JK08; Drug: Pembrolizumab |
| Dose Expansion Lenvatinib Combination Cohort - Hepatocellular Cancer | Experimental | JK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Lenvatinib will be given orally per standard institutional practice Receives: Drug: JK08; Drug: Lenvatinib Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity (DLT)
The incidence of DLTs during the DLT assessment period.
Measured: First 21 days of treatment.
Dose-Finding
Determination of the maximum-tolerated dose/recommended Phase 2 dose.
Measured: Screening to 90 days from last dose.
Safety and Tolerability
Incidence, nature, and severity of treatment-emergent adverse events [TEAEs]. Defined as any AE that occurs during the treatment period (i.e., after any treatment) and up to 28 days after the last dose of study treatment.
Measured: First treatment through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Safety and Tolerability
Incidence, nature, and severity of Serious Adverse Events [SAEs].
Measured: Screening date through 30 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Safety and Tolerability
Incidence, nature, and severity of adverse events [AEs].
Measured: Screening date through 30 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Secondary outcomes (6)
Pharmacokinetics of JK08
Maximum Plasma Concentration (Cmax)
Measured: Day 1 of dosing through 21 days post last dose.
Pharmacokinetics of JK08
Area Under the Curve (AUC)
Measured: Day 1 of dosing through 21 days post last dose.
Objective Response Rate (ORR)
ORR according to RECIST v1.1.
Measured: Day 1 of dosing through every 90 after the last dose.
Disease Control Rate (DCR)
The percentage of patients with a complete response, partial response, or stable disease for at least 2 consecutive tumor assessments.
Measured: ay 1 of dosing through every 90 after the last dose.
Progression Free Survival (PFS)
Time from the date of initiation of study therapy to the date measurement criteria are first met for progressive disease or death from any cause, whichever occurs first.
Measured: Day 1 of dosing through every 90 after the last dose.
Overall Survival (OS)
Time from the date of initiation of study therapy to the date of death from any cause.
Measured: Day 1 of dosing through every 90 after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start17 Oct 2022
- Primary completion17 Oct 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salubris Biotherapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620134
- Sponsor's protocol ID
- JK08.1.01
- Other IDs
- 2022-000339-21
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, Monotherapy or in Combination in Patients with Unresectable Locally Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT05620134
- Acronym / sponsor ID
- JK08.1.01
- Conditions
- Cancer, Tumor, Solid, Advanced Solid Tumor, Metastatic Cancer, Melanoma, Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 263 participants (estimated)
- Lead sponsor
- Salubris Biotherapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 17 Oct 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 17 Nov 2022 (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.
This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced or metastatic cancer.
Detailed description
This Phase 1/2, open label, dose escalation and cohort expansion study is designed to evaluate and characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of JK08 administered subcutaneously (SC) on a once weekly (QW) schedule in patients with unresectable locally, advanced or metastatic cancer.
The study consists of a Dose Escalation phase to determine the MTD/OBD of JK08, followed by a Cohort Expansion phase to further define the safety and initial efficacy of JK08 monotherapy or in combinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: JK08Escalating repeated doses of JK08 administered as a subcutaneous injection. A cycle of treatment is defined as 21 days, in which three doses of JK08 will be planned for administration. |
| Dose Expansion Pembrolizumab Combination Cohort - Non-Small Cell Lung Cancer | Experimental | Drug: JK08, Drug: PembrolizumabJK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Pembrolizumab will be given IV per standard institutional practice |
| Dose Expansion Pembrolizumab Combination Cohort - Colorectal Cancer | Experimental | Drug: JK08, Drug: PembrolizumabJK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Pembrolizumab will be given IV per standard institutional practice |
| Dose Expansion Lenvatinib Combination Cohort - Hepatocellular Cancer | Experimental | Drug: JK08, Drug: Lenvatinib PillJK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Lenvatinib will be given orally per standard institutional practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (54 listed)
- Age ≥ 18 years old.
- Signed informed consent and willing and able to comply with study procedures and scheduled visits.
- For Dose Escalation, patients with one of the following histologically diagnosed unresectable, locally advanced, or metastatic tumor types:
- Expansion Combination Cohorts
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Key exclusion criteria (36 listed)
- Patients with symptomatic or unstable CNS primary tumor or metastases and/or carcinomatous meningitis. Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator.
- Patients with active, or history of, severe autoimmune disease who in the opinion of the investigator and/or the Sponsor or Sponsor's designee would be exposed to unacceptable risk by participating in the study.
- Major surgery within 6 weeks from treatment initiation.
- Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose:
- Clinically significant gastrointestinal disorders including:
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 |
|---|---|---|
| JK08Recombinant fusion protein consisting of two functional elements, which are a fully human monoclonal antibody, directed against CTLA-4 and a protein complex formed by the human IL-15 and the Sushi domain of human IL-15Rα. | Drug | Dose Escalation, Dose Expansion Lenvatinib Combination Cohort - Hepatocellular Cancer, Dose Expansion Pembrolizumab Combination Cohort - Colorectal Cancer, Dose Expansion Pembrolizumab Combination Cohort - Non-Small Cell Lung Cancer |
| PembrolizumabImmune checkpoint inhibitor | Drug | Dose Expansion Pembrolizumab Combination Cohort - Colorectal Cancer, Dose Expansion Pembrolizumab Combination Cohort - Non-Small Cell Lung Cancer |
| Lenvatinib PillMulti-kinase inhibitor | Drug | Dose Expansion Lenvatinib Combination Cohort - Hepatocellular Cancer |
Primary outcome
Dose-limiting Toxicity (DLT)
Time frame: First 21 days of treatment.
The incidence of DLTs during the DLT assessment period.
Dose-Finding
Time frame: Screening to 90 days from last dose.
Determination of the maximum-tolerated dose/recommended Phase 2 dose.
Safety and Tolerability
Time frame: First treatment through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Incidence, nature, and severity of treatment-emergent adverse events [TEAEs]. Defined as any AE that occurs during the treatment period (i.e., after any treatment) and up to 28 days after the last dose of study treatment.
Safety and Tolerability
Time frame: Screening date through 30 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Incidence, nature, and severity of Serious Adverse Events [SAEs].
Safety and Tolerability
Time frame: Screening date through 30 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Incidence, nature, and severity of adverse events [AEs].
6 secondary outcomes
Pharmacokinetics of JK08
Time frame: Day 1 of dosing through 21 days post last dose.
Pharmacokinetics of JK08
Time frame: Day 1 of dosing through 21 days post last dose.
Objective Response Rate (ORR)
Time frame: Day 1 of dosing through every 90 after the last dose.
Disease Control Rate (DCR)
Time frame: ay 1 of dosing through every 90 after the last dose.
Progression Free Survival (PFS)
Time frame: Day 1 of dosing through every 90 after the last dose.
Overall Survival (OS)
Time frame: Day 1 of dosing through every 90 after the last dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JK08, Pembrolizumab and Lenvatinib Pill in people with Cancer and Tumor, Solid, run by Salubris Biotherapeutics Inc at 11 sites in 2 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 54 inclusion and 36 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, Belgium. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (DLT) (time frame: First 21 days of treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.