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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
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 \[2 weeks\]).
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 \[2 weeks\]).
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 \[3 weeks\]).
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGKorea University Anam Hospital
Seoul, South Korea
NOT_YET_RECRUITINGHanyang University Seoul Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSeverance Hospital, Yonsei University Health System
Seoul, South Korea
RECRUITINGPercentage of patients with DLTs by cohorts
To determine the MTD and RP2D based on safety and tolerability of GM103 as monotherapy (Parts A, B).
Time frame: during the first 28 days of treatment
Percentage of patients with DLTs
To determine the MTD and RP2D based on safety and tolerability of GM103 in combination with pembrolizumab (Part C)
Time frame: during the first 21 days of treatment
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)
Time frame: through study completion, and average 1 year
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)
Time frame: through study completion, and average 1 year
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)
Time frame: through study completion, an average of 1 year
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)
Time frame: through study completion, an average of 1 year
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)
Time frame: every cycle, through study completion, an average of 1 year [up to 12 treatment cycles, Part A&B: each cycle will consist of 14 days(2 weeks) / Part C: each cycle will consist of 21 days(3 weeks)]
Changes in the level of anti-adenovirus antibodies(ADA) in blood compared to baseline (ADA in genome copies/mL using qPCR)
* 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)
Time frame: every 2 cycles after the first cycle, through study completion, an average of 1 year [up to 12 treatment cycles, Part A&B: each cycle will consist of 14 days(2 weeks) / Part C: each cycle will consist of 21 days(3 weeks)]
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