TQB2916 Injection Combined With Chemotherapy or Penpulimab Injection in the Treatment of Solid Tumors

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT06500091
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TQB2916 injection + doxorubicin hydrochloride for injection — DRUG
    TQB2916 is a humanized immune gamma globulins 2 (IgG2) monoclonal antibody targeting CD40. The mechanism of action of doxorubicin is mainly to destroy the DNA structure of tumor cells, thereby killing malignant tumors. It interferes with the DNA synthesis process of cancer cells by targeting DNA and inhibiting enzymes in DNA replication and repair. In addition, doxorubicin can also trigger cross-link breaks in DNA, leading to apoptosis of cancer cells.
  • TQB2916 injection+penpulimab injection — DRUG
    TQB2916 is a humanized IgG2 monoclonal antibody targeting CD40. Penpulimab injection is a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor.

Study Details

This project is a clinical trial on the efficacy and safety of TQB2916 injection combined with chemotherapy or penpulimab injection in solid tumors. This project is divided into two cohorts. Cohort 1 aims to explore the safety and efficacy of specific subtypes of soft tissue sarcoma in subjects; Cohort 2 aims to explore safety and efficacy in subjects with undifferentiated pleomorphic sarcoma and melanoma. A total of 54 subjects are planned to be enrolled in this project.

Key Dates

First listed
Jul 15, 2024
Start date
Jul 31, 2024
Status verified
Oct 2023
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TQB2916 injection + doxorubicin hydrochloride for injection
    TQB2916 injection + doxorubicin hydrochloride for injection, 21 days as a treatment cycle.
  • Experimental: TQB2916 injection+penpulimab injection
    TQB2916 injection+penpulimab injection , 21 days as a treatment cycle.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 48 weeks ]

Central Contacts

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