Trials / Recruiting
RecruitingNCT06202261
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent / Metastatic Breast Cancer
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TQB2930 for injection | TQB2930 for injection is a HER2 bispecific antibody. |
| DRUG | Paclitaxel for injection (albumin-bound) | It is an anti-microtubule chemotherapy drug |
| DRUG | TQB3616 capsule | TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. |
| DRUG | Fulvestrant injection | Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol |
| DRUG | Capecitabine tablets | Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action. |
| DRUG | Vinorelbine tartrate injection | Vinorelbine is an anti-tumor drug of vinca alkaloids. |
| DRUG | Eribulin mesylate injection | Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism. |
| DRUG | gemcitabine hydrochloride for injection | Gemcitabine is a cell cycle specific anti-metabolic anticancer agent |
Timeline
- Start date
- 2023-04-13
- Primary completion
- 2026-12-01
- Completion
- 2027-10-01
- First posted
- 2024-01-11
- Last updated
- 2024-03-12
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06202261. Inclusion in this directory is not an endorsement.