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

NCT07281976 | Recruiting Phase 1 DMC

• 1 other identifier: LBL-024-CN005
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 7

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).

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR)

  According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).It was used to evaluate the efficacy in Phase Ib.

  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)

• Occurrence of adverse event (AE) and serious adverse event (SAE)

  Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 or LBL-024 Combination Administration will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.

  From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)

• Progression-free Survival(PFS)

  According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance in Phase II.

  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)

Secondary Outcomes (5)

• Cmax

  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)

• Tmax

  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)

• Immunogenicity

  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)

• Disease Control Rate(DCR)

  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)

• Duration of Response(DOR)

  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)

Study Arms (2)

LBL-024 + albumin-bound paclitaxel

EXPERIMENTAL

Experimental group： LBL-024 + albumin-bound paclitaxel. Intravenous infusion.

Drug: LBL-024 for Injection; Drug: albumin-bound Paclitaxel injection

Toripalimab + albumin-bound paclitaxel/albumin-bound paclitaxel

ACTIVE COMPARATOR

control group： Toripalimab + albumin-bound paclitaxel or albumin-bound paclitaxel. Intravenous infusion.

Drug: albumin-bound Paclitaxel injection; Drug: Toripalimab Injection

Interventions

Toripalimab Injection DRUG

Intravenous infusion.

Also known as: Toripalimab

Toripalimab + albumin-bound paclitaxel/albumin-bound paclitaxel

LBL-024 for Injection DRUG

Intravenous infusion.

Also known as: LBL-024

LBL-024 + albumin-bound paclitaxel

albumin-bound Paclitaxel injection DRUG

Intravenous infusion.

Also known as: albumin-bound Paclitaxel

LBL-024 + albumin-bound paclitaxel; Toripalimab + albumin-bound paclitaxel/albumin-bound paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Active infectious disease.
• Women with plans for pregnancy,Or women who are pregnant or breastfeeding.
• Active hepatitis B or active hepatitis C.
• History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (7)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510062, China

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

The first hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Injections; Albumin-Bound Paclitaxel; toripalimab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• yongmei Yin

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yongmei Yin

CONTACT

025-83718836; mengdongtao@leadsbiolabs.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)