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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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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\

• The expected survival time is at least 12 weeks.

• According to the evaluation of RECIST 1.1 (Response Evaluation Criteria in Solid Tumours),the subjects enrolled have at least one measurable lesion.

• 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 the signing of the informed consent form to within 6 months after the last administration of the trial drug,and do not donate sperm during this period.

Locations
Other Locations
China
The first hospital of Jilin University
RECRUITING
Changchun
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Jiangsu Province Hospital
RECRUITING
Nanjing
Liaoning Cancer Hospital
RECRUITING
Shenyang
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
yongmei Yin
mengdongtao@leadsbiolabs.com
025-83718836
Time Frame
Start Date: 2026-01-27
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 220
Treatments
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.
Sponsors
Leads: Nanjing Leads Biolabs Co.,Ltd
Collaborators: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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