RecruitingPhase 1NCT07376707

A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors


Sponsor

Hefei TG ImmunoPharma Co., Ltd.

Enrollment

194 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced/metastatic solid tumors. The study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study tests TGI-5, a new cancer drug, alone and combined with nivolumab (an immunotherapy), to assess safety and early effectiveness in adults with advanced or metastatic solid tumors — including colorectal cancer, melanoma, and non-small cell lung cancer — that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older with advanced solid tumors that have progressed on all standard therapies - You have colorectal cancer, melanoma, non-small cell lung cancer, or another advanced solid tumor - You have at least one measurable lesion on imaging - Your overall health status is good (ECOG 0–2) - Your liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to the brain (with some exceptions for previously treated, stable brain metastases) - You have active hepatitis B, hepatitis C, HIV, or tuberculosis - You have active autoimmune disease requiring systemic treatment - You have severe heart problems or had a heart attack in the past 6 months - You are pregnant or breastfeeding - You have previously received a TIGIT-targeting therapy 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

DRUGTGI-5

Subjects will receive TGI-5 as monotherapy in Phase 1a by Q2W for 28-day cycles. Subjects will receive TGI-5 in combination with Nivolumab in Phase 1b by Q2W for 28-day cycles.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07376707


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