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The sponsor has decided to terminate this study based on the current clinical research status of dual antibody drugs and full communication with the investigators.
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This study is divided into two phases: dose escalation and cohort expansion. The dose escalation stage aims to evaluate the tolerability, pharmacokinetic characteristics and safety of TQB2858 injection in subjects with advanced malignant tumors. The cohort expansion phase aims to evaluate the initial efficacy and safety of TQB2858 injection in patients with soft tissue sarcoma, and to explore treatment-related biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2858 injection | Experimental | Participants will receive 3 mg/60 mg/600 mg/1200 mg/1800 mg single dose of TQB2858 injection on Day 1, iv (injection of vein), once every three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2858 injection | Drug | TQB2858 is a Programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β(TGF-β) double antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD. | Baseline up to 48 weeks |
| Overall response rate (ORR) | ORR refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or iRECIST (CR and PR under iRECIST criteria can occur after imaging disease progression). | up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate(DCR) | DCR refers to the percentage of subjects with CR, PR, or stable disease (SD) of 6 weeks or more as determined by RECIST 1.1 or iRECIST (CR, PR, SD under iRECIST criteria can occur after imaging disease progression). | up to 48 weeks |
| Overall survival (OS) |
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Inclusion Criteria:
Phase I (dose-escalation phase).
a) Patients with advanced malignant solid/hematologic tumors who have a histologically and/or cytologically confirmed diagnosis and who have failed standard therapy or lack effective therapies.
Phase II (cohort expansion phase).
Age: 18 to 70 years old;
The Eastern Cooperative Oncology Group (ECOG) score: 0 to 1;
The expected survival period is ≥3 months;
Normal function of major organs
Women of childbearing age should agree to use effective contraceptive measures during the study period and 6 months after the end of the study, and have a negative serum or urine pregnancy test within 7 days before enrollment in the study; men should agree to use effective contraception during the study period and after the end of the study period 6 Effective contraceptive measures must be used within one month.
Patients voluntarily enroll in this study, sign an informed consent form and comply well.
Exclusion Criteria:
Combined diseases and medical history:
Tumor-related symptoms and treatment:
Research and treatment related:
Participation in other clinical trials of antineoplastic drugs within 4 weeks prior to enrollment.
Subjects who, in the judgment of the investigator, have a concomitant illness that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or for whom other reasons are deemed to exist for ineligibility for enrollment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Peking University People's Hospital |
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OS is defined as the time from enrollment to death from any cause. |
| Baseline up to die |
| Progression-Free Survival (PFS) | PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first. | up to 48 weeks |
| Duration of Response (DOR) | DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes. | up to 48 weeks |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Peking University Shougang Hospital | Beijing | Beijing Municipality | 100144 | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610000 | China |