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A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
Details
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 150 |
| Start date | 2024-02-01 |
| Completion | 2027-12 |
Conditions
- Advanced Cancer
Interventions
- TQB2922 for injection
Primary outcomes
- Dose limiting toxicity (DLT) — During the first treatment cycle (28 days).
DLT is defined as toxicities that meet pre-defined severity criteria according to the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 toxicity assessment criteria, and assessed as having a suspected relationship to study drug that occurred. - Maximum tolerated dose (MTD) — During the first treatment cycle (28 days).
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. - Adverse events (AEs) rate — From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.
The occurrence rate of all AEs during treatment - Adverse events (AEs) severity — From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.
The severity of all AEs occured during treatment
Countries
China