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New treatment option for Ovarian Cancer
Official title A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05746897
What this study is testing
What is NM1F Injection?
NM1F Injection is an investigational medicine, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people age ≥ 18 years at the time of informed consent.
- people with histologically or cytologically diagnosed unresectable locally advanced, or metastatic solid tumors, mainly but not limited to CRC, TNBC...
- people 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.
You likely can't join if
- 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...
- Has a history of symptomatic interstitial lung disease or inflammatory pneumonitis.
- Has a history of impaired cardiac function or clinically significant cardiovascular diseases.
See the full eligibility criteria
- Male or female people age ≥ 18 years at the time of informed consent.
- people 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...
- people 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.
- people have sufficient baseline organ function and laboratory data.
- Woman of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.
- Female people of childbearing potential or male people 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...
- 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...
- Has a history of symptomatic interstitial lung disease or inflammatory pneumonitis.
- Has a history of impaired cardiac function or clinically significant cardiovascular diseases.
- 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 people with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and...
- 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.
- people 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...
- people 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.
- people who have contraindication for use of PD-1/PD-L1 antibody (only for Phase 1b). \-
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.