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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT06202261
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TQB2930 for injection — DRUG
    TQB2930 for injection is a HER2 bispecific antibody.
  • Paclitaxel for injection (albumin-bound) — DRUG
    It is an anti-microtubule chemotherapy drug
  • TQB3616 capsule — DRUG
    TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
  • Fulvestrant injection — DRUG
    Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol
  • Capecitabine tablets — DRUG
    Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
  • Vinorelbine tartrate injection — DRUG
    Vinorelbine is an anti-tumor drug of vinca alkaloids.
  • Eribulin mesylate injection — DRUG
    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 hydrochloride for injection — DRUG
    Gemcitabine is a cell cycle specific anti-metabolic anticancer agent

Study Details

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).

Key Dates

Start date
Apr 13, 2023
Status verified
Mar 2024
Primary completion
Dec 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
154 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TQB2930 for injection
    TQB2930 for injection,10 mg/kg, quaque week (QW), 21 day as a treatment cycle; TQB2930 for injection, 20 mg/kg, quaque 2 weeks (Q2W), 28 day as a treatment cycle; TQB2930 for injection,30 mg/kg, quaque 3 weeks (Q3W), 21 day as a treatment cycle.
  • Experimental: TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)
    TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle
  • Experimental: TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection
    TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle.
  • Experimental: TQB2930 for injection + chemotherapy
    TQB2930 for injection 30mg/kg combined with capecitabine tablets or vinorelbine tartrate injection or eribulin mesylate injection or gemcitabine hydrochloride for injection, 21 days a cycle.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Baseline up to 4 months ]

Central Contacts

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