Spots Global Cancer Trial Database for A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics, and Antitumor Activity of TGI-6 as Monotherapy in Subjects With Locally Advanced/Metastatic Solid Tumors

Study ID: NCT06374173

Conditions

Advanced or Metastatic Solid Tumors

Interventions

TGI-6 Injection

Study Description

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

Detailed Description: 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 TGI-6 as monotherapy in subjects with unresectable locally advanced/metastatic CRC, or subjects with confirmed B7-H6-positive locally advanced/metastatic solid tumors. The study consists of two parts: a dose escalation part (Phase 1a) and a dose expansion part (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 including safety and survival follow-up.