Melanoma
Conditions
Brief summary
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.
Interventions
Humanized IgG4 mab targeting TIM-3
DRUGToripalimab injection
Monoclonal antibody against Programmed death factor receptor 1
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1 Age: 18-75 years old;ECOG PS score: 0\ 1;The expected survival is over 3 months * 2 Patients with advanced melanoma diagnosed histologically and/or cytologically * 3 At least one measurable lesion was confirmed according to RECIST 1.1 criteria * 4 Major organs are functioning normally * 5 Female subjects of reproductive age should agree to use contraceptive methods (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study;Negative serum pregnancy/urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;Male subjects should agree to use contraception during the study and for six months after the end of the study period
Exclusion criteria
* 1 Present or present with other malignant tumors within 3 years prior to first use * 2 Unalleviated toxicity above CTCAE grade 1 due to any prior treatment * 3 Major surgical treatment and significant traumatic injury were performed within 28 days prior to initial administration * 4 A wound or fracture that has not healed for a long time * 5 Those who have a history of psychotropic drug abuse and can't get rid of it or have mental disorders * 6 Subject with any severe and/or uncontrolled disease * 7 Prior chemotherapy within 3 weeks prior to initial drug use, and prior radiotherapy or other antineoplastic drugs within 2 weeks prior to initial drug use * 8 Those who have participated in and used other antitumor clinical trials within 4 weeks prior to the first drug use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity | Initial administration up to 21 days | Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose |
| phase II recommended dose | At the end of phase I, 1 subject received the first dose up to 21 days | Optimal tolerated dose determined after the end of phase 1 |
| objective response rate | Baseline up to 96weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | disease progression before death,no more than 100 months | The time between the onset of first medication and disease progression (PD) or death before PD |
| Disease Control Rate | Baseline up to 96 weeks | The ratio of disease control cases (Partial Remission+Complete Response+Partial Remission ) to total cases was calculated |
| Overall Survival | No more than 100 months from the beginning of the first dose to death | From the time of the patient's first treatment to the time of death from any cause |
Countries
China
Contacts
Primary ContactJun Guo, Doctor
Backup ContactSiMing Li, Doctor
Outcome results
None listed