RecruitingPhase 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 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

Sponsor

Hefei TG ImmunoPharma Co., Ltd.

Enrollment

38 participants

Start Date

Apr 13, 2023

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Melanoma

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new immunotherapy drug called NM1F in patients with advanced solid tumors. NM1F works by blocking a protein (PVRIG) that cancer cells use to hide from the immune system, potentially allowing the body to fight cancer more effectively. **You may be eligible if...** - You are 18 or older - You have advanced solid tumors (including colorectal cancer, triple-negative breast cancer, melanoma, or ovarian cancer) that have stopped responding to standard treatments - You have at least one measurable tumor on scans - Your general health is adequate (ECOG 0–2) - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have active brain tumors or brain metastases - You have an active autoimmune disease or are on chronic high-dose steroids - You have had serious infections recently - You are pregnant or breastfeeding - You have had severe allergic reactions to prior cancer therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNM1F Injection

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.

DRUGPembrolizumab injection