Clinical Study of QL1706 in Combination With Olaparib for the Treatment of Patients With Previously Treated Homologous Recombination Repair-Deficient Recurrent or Metastatic Triple-Negative Breast Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07005583
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Triple-Negative Breast Cancer (TNBC)

Eligibility Criteria

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

Interventions

  • QL1706 Plus Olaparib — DRUG
    QL1706: 5 mg/kg administered via intravenous (IV) infusion every 3 weeks (Q3W). Olaparib: 300 mg (two 150 mg tablets) taken orally twice daily (BID). Treatment will continue until protocol-defined discontinuation criteria are met, including disease progression, unacceptable toxicity, withdrawal of consent, or death.

Study Details

This is a single-arm, prospective, Phase II clinical trial designed to assess the efficacy and safety of QL1706 in combination with olaparib in patients with recurrent or metastatic triple-negative breast cancer (TNBC) harboring homologous recombination repair deficiency (HRD) who have received prior therapy.

Key Dates

Start date
Jun 30, 2025
Status verified
Jun 2025
Primary completion
May 30, 2027
Completion
May 20, 2030

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: QL1706 + Olaparib

Primary Outcome Measure

Progression-Free Survival (PFS) - investigator assessment [ Time Frame: Up to 2 years ]

Central Contacts

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