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Multiple escalating dose levels of GM103

(1 x 10\^11 vp, 3 x 10\^11 vp, 1 x 10\^12 vp, 3 x 10\^12 vp)

Dose expansion study of GM103 as monotherapy

(GM103 RP2D for HNC, GM103 RP2D for CRC)

Dose-escalation and dose-expansion of GM103 in combination with pembrolizumab

* Safety run in cohorts (GM103 1 dose level below RP2D + Pembrolizumab 200mg, GM103 RP2D + Pembrolizumab 200mg)
* Dose expansion (GM103 RP2D\*+ Pembrolizumab 200mg for HNC, GM103 RP2D\* + Pembrolizumab 200mg for CRC)

  * \*Recommended dose based on previous safety run in cohorts

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 \[2 weeks\]).

GM103 (Part A)

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 \[2 weeks\]).

GM103 (Part B)

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 \[3 weeks\]).

GM103 and Pembrolizumab (Part C)

KyoungRyun Park

YunJoo Lee

WY Choi

SH Lee

MS Chung

JY Lee

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:

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.

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

To determine the MTD and RP2D based on safety and tolerability of GM103 as monotherapy (Parts A, B).

To determine the MTD and RP2D based on safety and tolerability of GM103 in combination with pembrolizumab (Part C)

To evaluate overall safety profile of GM103 as monotherapy (Parts A, B) and in combination with pembrolizumab (Part C)

* To assess preliminary anti-tumor efficacy of GM103 at the RP2D, as monotherapy (Parts A and B)
* To assess preliminary anti-tumor efficacy of GM103 at the RP2D, in combination with pembrolizumab (Part C)

GeneMedicine Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors	NCT06265025	Head and Neck C... Malignant Melan... Colorectal Canc... Renal Cell Carc... Cervical Cancer Breast Cancer	GM103 (Part A) GM103 (Part B) GM103 and Pembr...	18 Years -	GeneMedicine Co., Ltd.
GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors	NCT06265025	Head and Neck C... Malignant Melan... Colorectal Canc... Renal Cell Carc... Cervical Cancer Breast Cancer	GM103 (Part A) GM103 (Part B) GM103 and Pembr...	18 Years -	GeneMedicine Co., Ltd.

Spots Global Cancer Trial Database for gm103 and pembrolizumab (part c)