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Terminated due to the adjustment of sponsor's development strategies and pipeline.
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This study is divided into three phases: single-dose exploration, combination dosage exploration and cohort expansion. The Single-dose exploration stage aims to evaluate the tolerability of TQB2858 injection in subjects with advanced pancreatic carcinoma. The Combination dosage exploration stage aims to evaluate the tolerance of TQB2858 injection combined with chemotherapy in patients with metastatic pancreatic cancer. The cohort expansion phase aims to evaluate the preliminary efficacy of TQB2858 injection combined with gemcitabine, albumin paclitaxel, and with or without anlotinib in patients with metastatic pancreatic cancer,and to explore treatment-related biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2858 injection | Experimental | Cohort 1: TQB2858 injection administered intravenously on day 1 of each 21-day cycle. Cohort 2: TQB2858 injection administered intravenously on day 1 of each 21-day cycle, gemcitabine and albumin paclitaxel administered intravenously on day 1 and day 7 of each 21-day cycle. Cohort 3: TQB2858 injection administered intravenously on day 1 of each 21-day cycle,gemcitabine and albumin paclitaxel administered intravenously on day 1 and day 7 of each 21-day cycle,Anlotinib capsules 8 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2858 injection | Drug | TQB2858 injection is a programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β bispecific antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | Grade 3 or 4 adverse events related to the study drug that occurred during cycle 1 | Baseline up to 3 weeks |
| Recommended phase II dose (RP2D) | Recommended dose for phase II | Baseline up to 3 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). | Baseline up to 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | Baseline up to 96 weeks |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
(1) Concomitant disease and medical history:
(2) Tumor-related symptoms and treatment:
(3) Research Treatment Related:
(4) Participated in other anti-tumor drug clinical trials within 4 weeks before the first medication or less than 5 drug half-livesï¼›
(5) Subject who, in the Investigator's judgment, has a concomitant disease that seriously endangers the subject's safety or affects the completion of the study, or is considered unsuitable for inclusion for other reasonsï¼›
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
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| Anlotinib Hydrochloride Capsule | Drug | Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor. |
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| Gemcitabine hydrochloride for injection | Drug | Chemotherapy medicine for metastatic pancreatic cancer |
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| Paclitaxel for injection (albumin bound) | Drug | Chemotherapy medicine for metastatic pancreatic cancer |
|
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).
| Baseline up to 30 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. | Baseline up to 30 weeks |
| 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. | Baseline up to 30 weeks |
| Overall survival (OS) | From randomization to the time of death from any cause. | Baseline up to 96 weeks |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D007267 | Injections |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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