Status: Recruiting
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).
Participants needed: 194
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hefei TG ImmunoPharma Co., Ltd.Updated: Jan 29, 2026Locations: 1
Eligibility criteria
1. Male or female subject age ≥18 years at the time of informed consent. 2. Phas... [+24]
1. Subject with known active central nervous system (CNS) primary tumor or metas... [+17]