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

NCT06265025 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-03-21

No results posted yet for this study

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:

Conditions

Interventions

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 \[3 weeks\]).

Sponsors & Collaborators

  • GeneMedicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • SH Lee · Korea University Anam Hospital

  • JY Lee · Severance Hospital, Yonsei University Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2025-05-30
Completion
2028-10-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06265025 on ClinicalTrials.gov