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
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
154 participants
Apr 13, 2023
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
TQB2930 for injection is a HER2 bispecific antibody.
It is an anti-microtubule chemotherapy drug
TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol
Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
Vinorelbine is an anti-tumor drug of vinca alkaloids.
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.
Gemcitabine is a cell cycle specific anti-metabolic anticancer agent
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06202261