LBL-024 alone or with chemotherapy for recurrent or metastatic triple-negative breast cancer

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

This trial tests whether LBL-024 by itself or together with albumin-bound paclitaxel can shrink tumors or slow disease in people with recurrent or metastatic triple-negative breast cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (Industry-sponsored)
• Locations: 7 sites (Guangzhou, Guangdong and 6 other locations)
• Trial ID: NCT07281976 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter phase Ib/II study that begins with small safety cohorts and may progress to a randomized expansion if early results are acceptable. Phase Ib Part A gives LBL-024 monotherapy to a small group to check safety, tolerability, and preliminary signs of activity, and Part B is a safety run-in of LBL-024 combined with albumin-bound paclitaxel if Part A is favorable. If safety and preliminary efficacy are acceptable, the study may proceed to a phase II randomized, open-label, positive-control expansion comparing combination regimens. Up to 220 participants with recurrent or metastatic triple-negative breast cancer and at least one measurable lesion may be enrolled across multiple Chinese cancer centers, with treatments that can include LBL-024, albumin-bound paclitaxel, and toripalimab.

Who should consider this trial

Good fit: Adults (≥18 years) with recurrent or metastatic triple-negative breast cancer, an ECOG performance status of 0–1, at least one measurable lesion, and an expected survival of at least 12 weeks are the intended candidates.

Not a fit: Patients with poor performance status (ECOG >1), very limited life expectancy, uncontrolled comorbidities, or who do not meet the study’s eligibility requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could offer a new treatment option that shrinks tumors or prolongs disease control for some people with recurrent or metastatic triple-negative breast cancer.

How similar studies have performed: Combining novel biologic agents with chemotherapy or immune checkpoint inhibitors has produced benefits in some TNBC subgroups in prior research, but LBL-024 itself is a novel agent with limited public data to date.

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 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.

Exclusion Criteria:

1. Use of immunomodulatory drugs within 2 weeks prior to first dose of study drug.
2. 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.
3. Patients with clinically uncontrolled pleural effusion, peritoneal effusion, or pericardial effusion.
4. Active infection within 2 weeks prior to first dose of study drug.
5. Active infectious disease.
6. Women with plans for pregnancy,Or women who are pregnant or breastfeeding.
7. Active hepatitis B or active hepatitis C.
8. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

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Where this trial is running

Guangzhou, Guangdong and 6 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• The first hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Principal investigator: yongmei Yin — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: yongmei Yin

Conditions Triple Negative Breast Cancer