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Recruiting Phase 1, Phase 2 NCT07281976

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

Trial Parameters

Condition Triple Negative Breast Cancer
Sponsor Nanjing Leads Biolabs Co.,Ltd
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 220
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-27
Completion 2027-12-31
Interventions
LBL-024 for Injectionalbumin-bound Paclitaxel injectionToripalimab Injection

Brief Summary

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).

Eligibility Criteria

Inclusion Criteria: 1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent. 2. At the time of signing the informed consent form, the age was ≥ 18 years old. 3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1. 4. The expected survival time is at least 12 weeks. 5. According to the evaluation of RECIST 1.1 (Response Evaluation Criteria in Solid Tumours),the subjects enrolled have at least one measurable lesion. 6. Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug; Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.Male patients are willing to take highly effective contraceptive measures From th

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