Spots Global Cancer Trial Database for GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors

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Trial Identification

Brief Title: GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors

Official Title: A Phase I/II, Open-label, Dose-escalation With Expansion Study of GM103 Via Intratumoral Injection, Alone and in Combination With Pembrolizumab in Adult Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors

Study ID: NCT06265025

Conditions

Interventions

GM103 (Part A)

GM103 (Part B)

GM103 and Pembrolizumab (Part C)

Study Description

Brief Summary: The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include:

Detailed Description: Part A, B * Primary Objectives * To determine the MTD and RP2D based on safety and tolerability of GM103 as monotherapy. * To evaluate overall safety profile of GM103 as monotherapy. * Secondary Objectives * To assess preliminary anti-tumor efficacy of GM103 at the RP2D, as monotherapy. Part C * Primary Objectives * To determine the MTD and RP2D based on safety and tolerability of GM103 in combination with pembrolizumab. * To evaluate overall safety profile of GM103 in combination with pembrolizumab . * Secondary Objectives * To assess preliminary anti-tumor efficacy of GM103 at the RP2D, in combination with pembrolizumab.