Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Antibodies

Paclitaxel

Gemcitabine

Albumin-Bound Paclitaxel

Antibodies, Bispecific

Immunoglobulins

Mitogens

Tyrosine Kinase Inhibitors

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Tyrosine

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).

TQB2858 injection is a programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β bispecific antibody.

TQB2858 injection

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Anlotinib Hydrochloride Capsule

Chemotherapy medicine for metastatic pancreatic cancer

Gemcitabine hydrochloride for injection

Paclitaxel for injection (albumin bound)

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.

A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma

Phase I Clinical Trial to Evaluate the Tolerability and Safety of TQB2858 Injection in Subjects With Metastatic Pancreatic Cancer

Grade 3 or 4 adverse events related to the study drug that occurred during cycle 1

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).

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

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).

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.

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.

From randomization to the time of death from any cause.

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

TQB2858 injection (1800mg intravenous(iv), on day 1 of every 3 weeks)

TQB2858 is a dual-function fusion protein that is aProgrammed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β(TGF-β) double antibody.

This study is a single-arm, open-label, multicenter Phase Ib clinical trial evaluating TQB2858 injection in the treatment of advanced high-grade sarcoma. To evaluate the preliminary efficacy and safety of TQB2858 injection in patients with advanced high-grade sarcoma, and to explore the relevant biomarkers of TQB2858 injection.

Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma

Single-arm, Open-label, Multicenter Phase Ib Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma

Objective response rate 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 modified RECIST1.1 for immune based therapeutics (iRECIST) (CR and PR under iRECIST criteria can occur after imaging disease progression).

Disease control rate 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).

Overall survival defined as the time from enrollment to death from any cause.

Pharmaceutical Solutions

TQB2858 administered intravenously (IV) once every 3 week

TQB2858 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2858 is diluted with normal saline \[0.9% (w/v) sodium chloride solution\], and the infusion time is 60 ± 10 min.

Ying Cheng, Doctor

This study is a phase I study to evaluate the safety and tolerability of TQB2858 injection in patients with advanced malignancy.

A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant Tumors

A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant Tumor

The incidence of all adverse events (AE), serious adverse events (SAE) and treatment-related adverse events (TEAEs)

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

TQB2858 is a Programmed cell death 1 ligand 1 (PD-L1)/transforming growth factor-β(TGF-β) double antibody.

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.

Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors

Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancies

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.

OS is defined as the time from enrollment to death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma	NCT05193604	Pancreatic Carc...	TQB2858 injecti... Anlotinib Hydro... Gemcitabine hyd... Paclitaxel for ...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma	NCT05262101	Advanced High-g...	TQB2858 injecti...	18 Years - 70 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma	NCT05193604	Pancreatic Carc...	TQB2858 injecti... Anlotinib Hydro... Gemcitabine hyd... Paclitaxel for ...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma	NCT05193604	Pancreatic Carc...	TQB2858 injecti... Anlotinib Hydro... Gemcitabine hyd... Paclitaxel for ...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma	NCT05193604	Pancreatic Carc...	TQB2858 injecti... Anlotinib Hydro... Gemcitabine hyd... Paclitaxel for ...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant Tumors	NCT04805060	Terminal Malign...	TQB2858 injecti...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors	NCT05154630	Advanced Cancer Advanced Soft-t...	TQB2858 injecti...	18 Years - 70 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma	NCT05262101	Advanced High-g...	TQB2858 injecti...	18 Years - 70 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors	NCT05154630	Advanced Cancer Advanced Soft-t...	TQB2858 injecti...	18 Years - 70 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for tqb2858 injection