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

NCT05262101 | Terminated Phase 2

• 1 other identifier: TQB2858-Ib-02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced High-grade Sarcoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  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).

  up to 48 weeks

Secondary Outcomes (4)

• Disease control rate (DCR)

  up to 48 weeks

• Overall survival (OS)

  Baseline up to die

• Progression-Free Survival (PFS)

  up to 48 weeks

• Duration of Response (DOR)

  up to 48 weeks

Study Arms (1)

TQB2858 injection

EXPERIMENTAL

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

Drug: TQB2858 injection

Interventions

TQB2858 injection DRUG

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.

TQB2858 injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed unresectable, recurrent or metastatic high-grade sarcoma;
• Received at least first-line therapy before, disease progression or intolerance during treatment, or disease progression after treatment; (excluding alveolar soft tissue sarcoma and clear cell sarcoma)
• Cohort 1: newly treated acinar soft tissue sarcoma;
• Cohort 2: Acinar soft tissue sarcoma with failed PD-1 therapy;
• Cohort 3: Other subtypes (pleomorphic sarcoma, classic osteosarcoma, Ewing sarcoma, chondrosarcoma, dedifferentiated liposarcoma, etc.).
• 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.

You may not qualify if:

• Combined diseases and medical history:
• Have presented with or currently have concurrent other malignancies within 2 years.
• Unresolved toxic reactions due to any prior treatment above Common Terminology Criteria for Adverse Events (CTCAE) grade 1, excluding alopecia, peripheral sensory nerve disorders.
• Major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment.
• Long-term untreated wounds or fractures.
• An arterial/venous thrombotic event within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism.
• Persons with a history of psychotropic substance abuse who are unable to abstain or have a mental disorder.
• Subjects with any severe and/or uncontrollable disease, including:
• Tumor-related symptoms and treatment:
• Received surgery, chemotherapy, radiotherapy, or other anticancer therapy within 4 weeks prior to the start of study treatment;
• Treatment with proprietary Chinese medicines with clear antitumor indications in the National Medical Products Administration (NMPA)-approved drug formulary within 2 weeks prior to the start of study treatment.
• Uncontrolled pleural effusions, pericardial effusions, or ascites that still require repeated drainage;
• Brain metastases with less than 4 weeks of stable symptom control after discontinuation of dehydrating agents and steroids.
• Research and treatment related:
• History of live attenuated vaccination within 28 days prior to the start of study treatment.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 2, 2022
• Study Start: May 9, 2022
• Primary Completion: June 28, 2023
• Study Completion: November 30, 2023
• Last Updated: January 22, 2024

Record last verified: 2023-03

Locations

CN (1)