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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Leads Biolabs Co.,Ltd

About this trial

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

Qualifiers

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.

At the time of signing the informed consent form, the age was ≥ 18 years old.

The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.

The expected survival time is at least 12 weeks.

Disqualifiers

Use of immunomodulatory drugs within 2 weeks prior to first dose of study drug.

Patients who received live vaccination within 4 weeks before the first dose of study drug or who are scheduled to receive live vaccination during the study treatment period and within 4 weeks after the last dose.

Patients with clinically uncontrolled pleural effusion, peritoneal effusion, or pericardial effusion.

Active infection within 2 weeks prior to first dose of study drug.

Trial design

Treatments tested in this trial

  • LBL-024 for Injection
  • albumin-bound Paclitaxel injection
  • Toripalimab Injection

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nanjing Leads Biolabs Co.,Ltd

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator