TQB2858 / Sino Biopharm - LARVOL DELTA

TQB2858-Ib-02: Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma (clinicaltrials.gov) - P2 | N=7 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=100 ➔ 7 | Not yet recruiting ➔ Terminated; 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.

Enrollment change • IO biomarker • Metastases • Trial termination • Oncology • Sarcoma • Solid Tumor

TQB2858-I-05: Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=8 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=147 ➔ 8 | Trial completion date: Dec 2023 ➔ Jun 2023 | Not yet recruiting ➔ Terminated | Trial primary completion date: Sep 2023 ➔ Mar 2023; 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.

Enrollment change • IO biomarker • Metastases • Trial completion date • Trial primary completion date • Trial termination • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma (clinicaltrials.gov) - P1 | N=29 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=104 ➔ 29 | Recruiting ➔ Terminated; Terminated due to the adjustment of sponsor's development strategies and pipeline.

Enrollment change • Trial termination • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BRCA • PD-L1

AN EXPLORATORY STUDY OF AN ANTI-PD-L1/TGF-β ANTIBODY, TQB2858, IN PATIENTS WITH REFRACTORY OR RECURRENT OSTEOSARCOMA AND ALVEOLAR SOFT PART SARCOMA: A REPORT FROM CHINESE SARCOMA STUDY GROUP (CTOS 2023) - "The combination of PD-L1 and TGF-β antibody TQB2858 did not significantly improve ORR in recurrent osteosarcoma. However, it did improve the immunogenic responses in ASPS even after progression upon anti-PD-1/PD-L1 therapy with an acceptable safety profile. IHC profiling with pathway enrichment analysis would have possibilities to have predictive value for survival outcome, necessitating further investigation to confirm."

Clinical • IO biomarker • Alveolar Soft Tissue Sarcoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • TGFB1

Exploratory study of an anti-PD-L1/TGF-β antibody, TQB2858, in patients with refractory or recurrent osteosarcoma and alveolar soft part sarcoma: a report from Chinese sarcoma study group (TQB2858-Ib-02). (PubMed, BMC Cancer) - "The combination of PD-L1 and TQB2858 did not significantly improve the ORR in patients with recurrent osteosarcoma. However, it improved immunogenic responses in ASPS, even after progression upon anti-PD-1/PD-L1 therapy, with an acceptable safety profile. IHC profiling with pathway enrichment analysis may not have any predictive value for survival outcomes."

IO biomarker • Journal • Alveolar Soft Tissue Sarcoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • TGFB1

A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BRCA • PD-L1

Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

IO biomarker • New P2 trial • Oncology • Sarcoma • Solid Tumor

To Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer (clinicaltrials.gov) - P1/2; N=90; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P1/2 trial • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Clinical Trial to Evaluate Tolerability and Security of TQB2858 Injection in Subjects With Advanced Pancreatic Carcinoma (clinicaltrials.gov) - P1; N=104; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Clinical • IO biomarker • New P1 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BRCA • PD-L1

TQB2858-I-05: Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2; N=147; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • IO biomarker • New P1/2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

A Clinical Trial to Evaluate Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancy (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cervical Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Clinical Trial to Evaluate TQB2858 Injection Combined With Anlotinib Hydrochloride Capsule in the Treatment of Recurrent or Metastatic Advanced Endometrial Carcinoma (clinicaltrials.gov) - P2; N=113; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P2 trial • Endometrial Cancer • Oncology • Solid Tumor