A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer

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).

Trial Details

NCT ID
NCT06202261
Phase
PHASE1 / PHASE2
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • TQB2930 for injection
  • Paclitaxel for injection (albumin-bound)
  • TQB3616 capsule
  • Fulvestrant injection
  • Capecitabine tablets
  • Vinorelbine tartrate injection
Locations (sample)
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Harbin, Heilongjiang, China|45.75,126.65

Key Eligibility Criteria

  • Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\~1; The expected survival is over 3 months.
  • Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;
  • Subjects with malignant tumors who have failed standard treatment or lack effective treatment;
  • Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find ER/PR Positive (Hormone Receptor Positive) Breast Cancer Trials on Trialify →