NCT06265025

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: GeneMedicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Malignant Melanoma
• Colorectal Cancer
• Renal Cell Carcinoma
• Cervical Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	GM103 (Part A)	dose escalation of GM103 as monotherapy, conducted in 12-24 patients. Part A will include a screening period of up to 28 days, a dose limiting toxicity (DLT) evaluation period of the first 2 cycles, and a treatment period from cycles 3-12 (each cycle will consist of 14 days \[2 weeks\]).
DRUG	GM103 (Part B)	dose expansion study of GM103 as monotherapy, conducted in up to 40 patients (a minimum of 20 patients per target disease \[HNC, CRC\]). Part B of the study will include a screening period of up to 28 days, and 1 to a maximum of 12 treatment cycles (each cycle will consist of 14 days \[2 weeks\]).
DRUG	GM103 and Pembrolizumab (Part C)	dose-escalation and dose-expansion of GM103 in combination with pembrolizumab, conducted in approximately 61 patients. Part C of the study will include a screening period of up to 28 days, a safety run-in period of 2 cycles (it consists of 2 cohorts and the first 1 cycle for the DLT assessment period of each cohort is included, each cycle will consist of 21 days \[3 weeks\]), and a dose expansion period from cycle 3 to a maximum of 12 treatment cycles (of 21 days \[3 weeks\]).

Timeline

• Start date: 2024-02-20
• Primary completion: 2025-05-30
• Completion: 2028-10-30
• First posted: 2024-02-20
• Last updated: 2024-03-21

Locations

4 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study