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:
Patient must be 18 years of age or over, at the time of signing the informed consent.
Have a diagnosis of locally advanced, unresectable, refractory and/or metastatic solid tumors
Have a tumor that is accessible and is willing to consent to tumor biopsies during the study.
Have at least one measurable site of disease according to RECIST 1.1 criteria; The lesions should be either previously non irradiated or progressive lesions after irradiation, that can be accurately measured at baseline (for measurable lesions) with computed tomography (CT) or magnetic resonance imaging (MRI).
Known history or eiciency virus [HIV]/acquired immunodeficiency syndrome [AIDS]) and/or medication.
Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisolone equivalent) or other immunosuppressive medications within 14 days of the first dose of study treatment.
Patients with a history of, or active, known or suspected auto-immune disease or a syndrome that requires systemic or immunosuppressive agents.
Active infections requiring antibiotics, physician monitoring or recurrent fevers (>38.0 ̊C) associated with a clinical diagnosis of active infection.
Sequential
GM103 (Part A)
Drugdose 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 B)
Drugdose 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 and Pembrolizumab (Part C)
Drugdose-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 \[3 weeks\]).
Percentage of patients with DLTs by cohorts
To determine the MTD and RP2D based on safety and tolerability of GM103 as monotherapy (Parts A, B).
Percentage of patients with DLTs
To determine the MTD and RP2D based on safety and tolerability of GM103 in combination with pembrolizumab (Part C)
Incidence of AEs, AESIs, SAEs, AEs leading to discontinuation, and AEs resulting in death
To evaluate overall safety profile of GM103 as monotherapy (Parts A, B) and in combination with pembrolizumab (Part C)
ORR
* 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)
DCR defined as the proportion of patients whose BOR was CR, PR and SD
* 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)
Median PFS defined as the time from the date of the first administration of study drug to the date of disease progression or death
* 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)
Incidence of GM103 detection
* 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)
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