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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

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 criteria

Qualifiers

Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0~1; The expected survival is over 3 months.

Phase Ib

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;

Disqualifiers

Have occured other malignant tumors within 3 years prior to first dose.

Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;

Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;

Long-term unhealed wounds or fractures;

Trial design

Treatments tested in this trial

  • TQB2930 for injection
  • Paclitaxel for injection (albumin-bound)
  • TQB3616 capsule
  • Fulvestrant injection
  • Capecitabine tablets
  • Vinorelbine tartrate injection
  • Eribulin mesylate injection
  • gemcitabine hydrochloride for injection

Treatment groups

154 Participants
are divided into 4 treatment groups