Study of GI-102 Alone and with Pembrolizumab or Trastuzumab Deruxtecan for Advanced or Metastatic Solid Tumors Phase 12 Open-label Dose Escalation and Expansion Trial Evaluating Safety, Tolerability, and Anti-Tumor Activity

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and therapeutic effects of GI-102, a novel bispecific fusion protein, as a single treatment and in combination with conventional anti-cancer drugs like pembrolizumab or trastuzumab deruxtecan T-DXd for advanced or metastatic solid tumors. This phase 12, open-label study includes patients with various cancer types including melanoma, breast, colorectal, and others. The study aims to define safe dosing and explore how GI-102 interacts with the immune system to impact tumor growth. The study has four parts Part A focuses on dose escalation and optimization of GI-102 given intravenously Part B involves dose escalation and expansion of GI-102 given subcutaneously Parts C and D explore GI-102 combined with other anti-cancer drugs in specific cancer types. GI-102 is administered either intravenously or by subcutaneous injection every three weeks for up to two years. The combination drugs are given according to their usual schedules alongside GI-102. Participants will undergo regular monitoring for dose-limiting toxicities, adverse events, and immune-related side effects throughout the study and for up to 24 months. Researchers will measure tumor response rates, disease control, survival, and pharmacokinetic properties of GI-102. All participants will have physical exams, laboratory tests, and imaging scans to assess safety and treatment effects during scheduled visits over the course of the trial.

A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)