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

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).

Trial Details

NCT ID
NCT07376707
Phase
PHASE1
Sponsor
Hefei TG ImmunoPharma Co., Ltd.
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • TGI-5
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • 1\. Male or female subject age ≥18 years at the time of informed consent. 2. Phase 1a and dose escalation part of Phase 1b: Subjects with histologi…
  • Dose expansion part of Phase 1b:
  • Cohort 1: Subjects with histologically or cytologically diagnosed unresectable locally advanced and/or metastatic CRC.
  • Cohort 2: Subjects with histologically or cytologically diagnosed unresectable locally advanced and/or metastatic melanoma.

For full eligibility, visit ClinicalTrials.gov.

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