drugset / Trial / NCT06202261
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).
Timeline
- Start
- 2023-04-13
- Primary completion
- 2026-12
- Completion
- 2027-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Eribulin | Small molecule | — | — |
| Subject | Fulvestrant | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Subject | TQB2930 | Unknown | 10 mg/kg | — |
| Subject | TQB2930 | Unknown | 20 mg/kg | — |
| Subject | TQB2930 | Unknown | 30 mg/kg | — |
| Subject | TQB3616 | Small molecule | 120 mg | — |
| Subject | TQB3616 | Small molecule | 150 mg | — |
| Subject | TQB3616 | Small molecule | 180 mg | — |
| Subject | Vinorelbine | Small molecule | — | — |