A Study of GQ1010 in Subjects With Advanced Solid Tumors
NCT Number: NCT06464055
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Malignant Solid Tumors
Interventions: DRUG: Dose Escalation|DRUG: Dose Expansion1|DRUG: Dose Expansion2|DRUG: phase II
Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-23
Completion Date: 2028-12-31
Locations: Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, China|Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China|Tianjin medical university cancer institute & hospital, Tianjin, China|Hubei Cancer Hospital, Wuhan, China|The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

Summary:
This is an open-label, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of GQ1010 and preliminary anti-tumor efficacy in advanced malignant solid tumor subjects

Primary Outcome Measures: Phase I/II: Incidence and Severity of Adverse Events (AEs), Incidence and severity of Treatment-emergent adverse events, treatment-related adverse events and serious adverse events, according to NCI-CTCAE Version 5.0 (The number of participants who had treatment-related side effects in population who had received one therapy at least).

Incidence and severity of TEAEs, TRAE and SAE, Screening up to study completion, an average of 1 year|Phase Ia: Dose Limiting Toxicities (DLTs), Adverse events will be assessed using NCI CTCAE version 5.0 and will be evaluated by the investigator and the sponsor for the eligibility of DLT., From first dose to the end of Cycle 1, 21 days|Phase Ia: Maximal Tolerance Dose (MTD) or recommended doses for dose expansion (RDEs), The SRC will determine the MTD/RDEs based on the totality of data for all tested dose levels., After each cohort completes the DLT observation period (Day 1 to Day 21 after the first dose of study treatment) or has a DLT or becomes not DLT-evaluable|Phase Ib: Recommended phase II dose (RP2D), The SRC will also determine the RP2D based on the totality and efficacy of data for all tested dose levels., After each cohort completes the safety and efficacy evaluation, an average of 6 months|Phase II: Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of CR and PR., Screening up to study completion, an average of 1 year
Secondary Outcome Measures: Maximum concentration (Cmax) of GQ1010, The pharmacokinetics(PK) profile of GQ1010, Screening up to study completion, an average of 1 year|Time of peak plasma concentration (Tmax), The pharmacokinetics(PK) profile of GQ1010, Screening up to study completion, an average of 1 year|Area under the plasma concentration time curve (AUC) of GQ1010, The pharmacokinetics(PK) profile of GQ1010, Screening up to study completion, an average of 1 year|Terminal half-life (T1/2) of GQ1010, The pharmacokinetics(PK) profile of GQ1010, creening up to study completion, an average of 1 year|Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat)., Screening up to study completion, an average of 1 year|Duration of response (DOR) determined by investigators according to RECIST 1.1, DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]., Screening up to study completion, an average of 1 year|Disease control rate (DCR) determined by investigators according to RECIST 1.1, Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD)., Screening up to study completion, an average of 1 year|Progression-free survival (PFS) determined by investigators according to RECIST 1.1, Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from first dose to PD or death from any cause., Screening up to study completion, an average of 1 year|Overall survival (OS) (only in dose expansion stage), OS was defined as the time from first dose to death from any cause., Screening up to study completion, an average of 1 year|Immunogenicity (anti-drug antibody ADA), Percentage of subjects producing detectable anti-drug antibodies (ADA), Screening up to study completion, an average of 1 year