LBL-024 alone or combined with LBL-007 or toripalimab for advanced melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter Phase Ib/II program enrolling up to 200 adults with advanced melanoma to study LBL-024 as monotherapy and in two combination regimens. Phase Ib is a single-arm, exploratory safety and activity assessment with three cohorts (LBL-024 alone, LBL-024 + LBL-007, LBL-024 + toripalimab). Phase II includes a randomized, open-label Part A (2:1 randomization versus a positive control, stratified by acral subtype) and a single-arm Part B expansion for mucosal melanoma, with the Part B regimen chosen based on Phase Ib results. The trial requires scheduled clinic visits and collection of biological samples for testing and safety monitoring across multiple Chinese cancer centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Agree to follow the trial treatment regimen, visit schedule,laboratory test, and comply with 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, and the gender was not limited.
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 neoplasm lesion.
6. Male of childbearing potential and 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.

Exclusion Criteria:

1. Subjects who received live vaccination within 4 weeks before the first dose or were planned to receive live vaccination during the study period and 4 weeks after the dose.
2. Major surgery or other treatment or diagnosis that has a significant impact on the participant within 4 weeks before the first dose.
3. Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
4. History of severe cardiovascular and cerebrovascular disorder.
5. Active infectious disease.
6. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
7. Women during pregnancy or lactation.
8. The investigator believes that the participant has other conditions that may affect compliance or are not suitable for participating in this study.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Guangxi Medical University Cancer Hospital
  Nanning, Guangxi, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Principal investigator: Yu Chen — Fujian Cancer Hospital
• Study coordinator: Yu Chen
• Email: maxy@leadsbiolabs.com
• Phone: 025-83378099

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

• Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer

  This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07896681

• Propranolol with Toripalimab and Platinum Chemo before/around surgery in NSCLC

  This study tests whether adding propranolol to toripalimab and platinum-based chemotherapy is safe and tolerable for people with resectable non-small cell lung cancer before surgery.

  Recruiting Phase 1 Second Xiangya Hospital of Central South University · Changsha, Hunan and 3 other locations · NCT07886229

• Neoadjuvant Cryo-Thermal Ablation with Toripalimab and Chemo for Resectable NSCLC

  This study tests whether using Cryo-Thermal Ablation before chemo-immunotherapy helps people with resectable NSCLC see better outcomes.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan and 8 other locations · NCT07855965

• Rimegepant plus toripalimab in advanced urothelial cancer after standard therapy

  This small, early-stage study tests whether combining rimegepant with toripalimab is safe and shows signs of activity in adults with advanced urothelial cancer that did not respond to prior treatment.

  Recruiting at 2 sites Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality and 1 other locations · NCT07835035

• SABR with Axitinib and Toripalimab for oligometastatic kidney cancer

  This phase 2 trial tests whether giving SABR radiation together with axitinib and toripalimab can shrink tumors and help patients with up to five metastatic sites from clear cell renal cell carcinoma.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07744932

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.