Ovarian CancerPhase 1NCT05746897
A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors
A Phase 1 study testing NM1F Injection and Pembrolizumab injection in people with Ovarian Cancer and Melanoma, run by Hefei TG ImmunoPharma Co., Ltd. at 2 sites in United States.
Trial summary
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination with Pembrolizumab in Subjects with Locally Advanced/Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Melanoma, Triple Negative Breast Cancer
- What is being tested?
- NM1F Injection and Pembrolizumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Apr 2023to 30 Sep 2027
- 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
- Male or female subjects age ≥ 18 years at the time of informed consent.
- Subjects with histologically or cytologically diagnosed unresectable locally advanced, or metastatic solid tumors, mainly but not limited to CRC, TNBC, melanoma, OC, and who have progressed despite all standard therapy or are intolerant of all standard therapy, or for whom no effective standard therapy exists
- Subjects must have at least 1 evaluable lesion as defined by response evaluation criteria in solid tumors (RECIST) v1.1.
- ECOG PS of 0~2.
- Life expectancy ≥ 3 months.
- Subjects have sufficient baseline organ function and laboratory data.
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- Woman of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.
- Female subjects of childbearing potential or male subjects with a partner of childbearing potential must agree to use effective contraception at the time of informed consent and continuing through the study until 6 months after the last dose of NM1F and / or pembrolizumab.
- -
Who cannot join
- Cancer Related
- Subject with known active central nervous system (CNS) primary tumor or metastases.
- History of intercurrent severe chronic or active infections.
- Has a history of active autoimmune diseases , or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study drug.
- Has a history of symptomatic interstitial lung disease or inflammatory pneumonitis.
- Has a history of impaired cardiac function or clinically significant cardiovascular diseases.
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- Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years (Note: Exceptions are subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and localized prostate cancer who have undergone potentially curative therapy. These subjects are not excluded).
- Evidence of clinically significant immunosuppression such as the following:
- Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease (SCID)
- Concurrent opportunistic infection
- Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (monthly or more frequently).
- Has received prior anticancer treatment with the following therapies (specified time periods are from last dose of prior treatment to first dose of NM1F):
- Any therapy directed against PVRIG (COM701 or other anti-PVRIG mAb) or other CD226 axis receptor (TIGIT or CD96) at any time.
- Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
- Prior radiotherapy ≤ 4 weeks prior to the first dose of study treatment, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted.
- Investigational therapy: if the subject has participated in a clinical study and has received an investigational product within 4 weeks prior to the first dose of study treatment.
- Has received systematic immunomodulatory drugs within 14 days before the first dose of study drug, such as thymosin, IL-2, IFN.
- Has received a live vaccine within 4 weeks prior to the first dose of study drug.
- Has a recent major surgery within 4 weeks prior to the first dose of study drug or is expected to undergo major surgery during the study.
- Toxicities of prior therapies have not been resolved to ≤ Grade 1 or baseline as per NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation.
- Subjects who have experienced Grade ≥ 3 irAEs from prior immunotherapies or who discontinue immunotherapy due to immune-related toxicities.
- Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
- Pregnancy or lactation. Women who are willing to discontinue breastfeeding prior to administration of study drug and do not intend to resume breastfeeding may be enrolled.
- Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the investigator.
- Subjects who are unwilling or unable to comply with study procedures and study restrictions, or in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Subjects who have contraindication for use of PD-1/PD-L1 antibody (only for Phase 1b).
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NEXT Oncology, Dallas
Dallas, Texas, 75039
Erica Torres, 737-610-5205, etorres@nextoncology.com
- Recruiting
Next Oncology, Virginia Cancer Specialists
Fairfax, Virginia, 22031
Blake Patterson, 703-783-4505, bpatterson@nextoncology.com
About this study
Official title: A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally Advanced/Metastatic Solid Tumors
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination with Pembrolizumab in Subjects with Locally Advanced/Metastatic Solid Tumors
Read the detailed description
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally advanced, or metastatic solid tumors.
The study consists of two parts : NM1F monotherapy dose escalation (Phase 1a), NM1F dose escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (1 year and 2 years for Phase 1a and 1b, respectively, or until treatment discontinuation), and a follow-up period .
- Being tested
- NM1F Injection, Pembrolizumab injection
- Keywords
- solid tumors，NM1F，Pembrolizumab
- Medical subject headings
- Ovarian Neoplasms, Melanoma, Triple Negative Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM1F InjectionDrug
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally advanced, or metastatic solid tumors.
The study consists of two parts: NM1F monotherapy dose escalation (Phase 1a), NM1F dose escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (until treatment discontinuation), and a follow-up period.
Pembrolizumab injectionDrug
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally advanced, or metastatic solid tumors.
The study consists of two parts: NM1F monotherapy dose escalation (Phase 1a), NM1F dose escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (until treatment discontinuation), and a follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| NM1F Injection/pembrolizumab Injection | Experimental | NM1F monotherapy dose escalation(Phase 1a) NM1F dose escalation in combination with a fixed dose of pembrolizumab(Phase 1b) Receives: Drug: NM1F Injection; Drug: Pembrolizumab injection |
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 MTD or maximum tested dose, and the RP2D.
Measured: Approximately 3 years.
Frequency and Severity of Adverse Events (AE)
The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
Measured: Screening to 30 days from last dose
Secondary outcomes (8)
Pharmacokinetics of NM1F
Maximum Plasma Concentration (Cmax)
Measured: Day 1 of dosing through 30 days post last dose
Pharmacokinetics of NM1F
Area Under the Curve (AUC)
Measured: Day 1 of dosing through 30 days post last dose
Number of subjects with Anti-NM1F antibody positive .
Immunogenicity of NM1F monotherapy and in combination with pembrolizumab
Measured: Day 1 of dosing through 30 days post last dose
Objective Response Rate (ORR)
ORR according to RECIST v1.1.
Measured: Approximately 3 years.
Duration of Response (DoR)
Time from the date measurement criteria are first met for PR or CR to the date measurement criteria are first met for progressive disease.
Measured: Approximately 3 years.
Disease Control Rate (DCR)
The proportion of subjects who have best overall response of CR or PR, or stable disease (SD).
Measured: Approximately 3 years.
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: Approximately 3 years.
Overall Survival (OS)
Time from the date of initiation of study therapy to the date of death from any cause.
Measured: Approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start13 Apr 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hefei TG ImmunoPharma Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746897
- Sponsor's protocol ID
- NM1F-T1-01
- Status last verified
- Jan 2024
- First submitted
- 3 Feb 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05746897
- Acronym / sponsor ID
- NM1F-T1-01
- Keywords
- solid tumors，NM1F，Pembrolizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Hefei TG ImmunoPharma Co., Ltd.University, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Feb 2023 (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.
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination with Pembrolizumab in Subjects with Locally Advanced/Metastatic Solid Tumors
Detailed description
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally advanced, or metastatic solid tumors.
The study consists of two parts : NM1F monotherapy dose escalation (Phase 1a), NM1F dose escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (1 year and 2 years for Phase 1a and 1b, respectively, or until treatment discontinuation), and a follow-up period .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NM1F Injection/pembrolizumab Injection | Experimental | Drug: NM1F Injection, Drug: Pembrolizumab injectionNM1F monotherapy dose escalation(Phase 1a) NM1F dose escalation in combination with a fixed dose of pembrolizumab(Phase 1b) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects age ≥ 18 years at the time of informed consent.
- Subjects with histologically or cytologically diagnosed unresectable locally advanced, or metastatic solid tumors, mainly but not limited to CRC, TNBC, melanoma, OC, and who have progressed despite all standard therapy or are intolerant of all standard therapy, or for whom no effective standard therapy exists
- Subjects must have at least 1 evaluable lesion as defined by response evaluation criteria in solid tumors (RECIST) v1.1.
- ECOG PS of 0~2.
- Life expectancy ≥ 3 months.
Key exclusion criteria (29 listed)
- Cancer Related
- Subject with known active central nervous system (CNS) primary tumor or metastases.
- History of intercurrent severe chronic or active infections.
- Has a history of active autoimmune diseases , or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study drug.
- Has a history of symptomatic interstitial lung disease or inflammatory pneumonitis.
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 |
|---|---|---|
| NM1F InjectionThis is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally advanced, or metastatic solid tumors. The study consists of two parts: NM1F monotherapy dose escalation (Phase 1a), NM1F dose escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (until treatment discontinuation), and a follow-up period. | Drug | NM1F Injection/pembrolizumab Injection |
| Pembrolizumab injectionThis is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally advanced, or metastatic solid tumors. The study consists of two parts: NM1F monotherapy dose escalation (Phase 1a), NM1F dose escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (until treatment discontinuation), and a follow-up period. | Drug | NM1F Injection/pembrolizumab Injection |
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: Approximately 3 years.
Determination of the MTD or maximum tested dose, and the RP2D.
Frequency and Severity of Adverse Events (AE)
Time frame: Screening to 30 days from last dose
The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.
8 secondary outcomes
Pharmacokinetics of NM1F
Time frame: Day 1 of dosing through 30 days post last dose
Pharmacokinetics of NM1F
Time frame: Day 1 of dosing through 30 days post last dose
Number of subjects with Anti-NM1F antibody positive .
Time frame: Day 1 of dosing through 30 days post last dose
Objective Response Rate (ORR)
Time frame: Approximately 3 years.
Duration of Response (DoR)
Time frame: Approximately 3 years.
Disease Control Rate (DCR)
Time frame: Approximately 3 years.
Progression Free Survival (PFS)
Time frame: Approximately 3 years.
Overall Survival (OS)
Time frame: Approximately 3 years.
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 26 Jan 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NM1F Injection and Pembrolizumab injection in people with Ovarian Cancer and Melanoma, run by Hefei TG ImmunoPharma Co., Ltd. at 2 sites in United States.
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 9 inclusion and 29 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Xiaohu Zheng, Doctorate (+86-13956959849, xiaohu.zheng@tgimmunopharma.com), or a site near the patient. 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 3 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 26 Jan 2024.