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OncoMatch/Clinical Trials/NCT06265025

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

Is NCT06265025 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including GM103 (Part A) and GM103 (Part B) for head and neck cancer.

Phase 1/2RecruitingGeneMedicine Co., Ltd.NCT06265025Data as of May 2026

Treatment: GM103 (Part A) · GM103 (Part B) · GM103 and Pembrolizumab (Part C)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:

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Melanoma

Colorectal Cancer

Renal Cell Carcinoma

Cervical Cancer

Breast Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: systemic anticancer therapy

Treatment with any systemic anticancer therapies for locally advanced or metastatic within 4 weeks or 6 half-lives of prior anticancer therapy, whichever is shorter, prior to initiation of study treatment

Cannot have received: oncolytic virus (GM103)

Previous treated with GM103 or other oncolytic viruses

Cannot have received: radiation therapy

Radiation therapy within 2 weeks prior to enrollment

Cannot have received: antiviral agent

Use of the antiviral agents within 7 days prior to the first dose of study treatment; or pegylated interferon in the 14 days before the first dose of study treatment

Cannot have received: live vaccine

Patients who have received a live vaccine within 30 days of study enrollment

Cannot have received: investigational drug

Administration of an investigational drug in the 28 days before the first dose of study treatment

Lab requirements

Cardiac function

ejection fraction (ef) > 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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