NCT07281976 A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer
| NCT ID | NCT07281976 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Nanjing Leads Biolabs Co.,Ltd |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 220 participants in total. It began in 2026-01-27 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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. \-
Contact & Investigator
yongmei Yin
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT07281976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07281976 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07281976 currently recruiting?
Yes, NCT07281976 is actively recruiting participants. Contact the research team at mengdongtao@leadsbiolabs.com for enrollment information.
Where is the NCT07281976 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Harbin, China, Zhengzhou, China and 3 additional locations.
Who is sponsoring the NCT07281976 clinical trial?
NCT07281976 is sponsored by Nanjing Leads Biolabs Co.,Ltd. The principal investigator is yongmei Yin at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 220 participants.
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