A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer

Sponsor
Nanjing Leads Biolabs Co.,Ltd
Study ID
NCT07281976
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LBL-024 for Injection — DRUG
    Intravenous infusion.
  • albumin-bound Paclitaxel injection — DRUG
    Intravenous infusion.
  • Toripalimab Injection — DRUG
    Intravenous infusion.

Study Details

This trial is an open-label, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of LBL-024 monotherapy or in combination with albumin-bound paclitaxel in patients with recurrent or metastatic triple negative breast cancer(TNBC).

Key Dates

First listed
Dec 15, 2025
Start date
Jan 27, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LBL-024 + albumin-bound paclitaxel
    Experimental group： LBL-024 + albumin-bound paclitaxel. Intravenous infusion.
  • Active Comparator: Toripalimab + albumin-bound paclitaxel/albumin-bound paclitaxel
    control group： Toripalimab + albumin-bound paclitaxel or albumin-bound paclitaxel. Intravenous infusion.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) ]

Central Contacts

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