Trials / Not Yet Recruiting
Not Yet RecruitingNCT06500091
TQB2916 Injection Combined With Chemotherapy or Penpulimab Injection in the Treatment of Solid Tumors
A Multicenter, Open-Label, Single-Arm, Multi-Cohort Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB2916 Injection in Combination With Chemotherapy or in Combination With Penpulimab Injection for Solid Tumors
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TQB2916 injection + doxorubicin hydrochloride for injection | 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. |
| DRUG | TQB2916 injection+penpulimab injection | TQB2916 is a humanized IgG2 monoclonal antibody targeting CD40. Penpulimab injection is a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor. |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2026-06-01
- Completion
- 2026-12-01
- First posted
- 2024-07-15
- Last updated
- 2024-07-15
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06500091. Inclusion in this directory is not an endorsement.