A Phase 1 interventional study of TQB2618 injection and Toripalimab injection in Melanoma, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment
This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 50 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TQB2618 injection combined with Toripalimab injection，21 days as a treatment cycle.
Drug: TQB2618 injection · Drug: Toripalimab injection
Humanized IgG4 mab targeting TIM-3
Monoclonal antibody against Programmed death factor receptor 1
Dose-limiting toxicity
Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose
Time frame: Initial administration up to 21 days
phase II recommended dose
Optimal tolerated dose determined after the end of phase 1
Time frame: At the end of phase I, 1 subject received the first dose up to 21 days
objective response rate
The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit (at the time of the next imaging evaluation)
Time frame: Baseline up to 96weeks
Progression-Free Survival
The time between the onset of first medication and disease progression (PD) or death before PD
Time frame: disease progression before death,no more than 100 months
Disease Control Rate
The ratio of disease control cases (Partial Remission+Complete Response+Partial Remission ) to total cases was calculated
Time frame: Baseline up to 96 weeks
Overall Survival
From the time of the patient's first treatment to the time of death from any cause
Time frame: No more than 100 months from the beginning of the first dose to death
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.