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Recruiting Phase 1 NCT06374173

A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors

Trial Parameters

Condition Advanced or Metastatic Solid Tumors
Sponsor Hefei TG ImmunoPharma Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 123
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-03
Completion 2027-09
Interventions
TGI-6 Injection

Brief Summary

A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors

Eligibility Criteria

Inclusion Criteria: 1. Male or female subjects age ≥18 years at the time of informed consent. 2. Phase 1a: Subjects with histologically or cytologically diagnosed unresectable locally advanced/metastatic CRC. Or subjects with confirmed B7-H6-positive unresectable locally advanced/metastatic solid tumors, mainly but not limited to TNBC, HCC, HNSCC, SCLC, OC, GC, pancreatic cancer, and melanoma. Phase 1b Cohort 1: Subjects must have pathologically documented, definitively diagnosed unresectable locally advanced and/or metastatic CRC. Phase 1b Cohort 2: Subjects must have pathologically documented, definitively diagnosed unresectable locally advanced and/or metastatic solid tumors with B7-H6-positive, mainly but not limited to TNBC, HCC, HNSCC, SCLC, OC, GC, pancreatic cancer, and melanoma. 3. Phase 1a or Phase1b Cohort 2: Subjects should have progressed despite all standard therapy or be intolerant of all standard therapy, or for whom no standard therapy exists. (Standard therapies are d

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