Evaluating LBL-007 with Toripalimab and Axitinib 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 phase I clinical trial is designed to assess the safety and efficacy of LBL-007 in combination with Toripalimab and Axitinib for patients with advanced melanoma. The study is structured into two parts: a dose-escalation phase and a dose-expansion phase, where participants will receive the treatment and be monitored for safety, tolerability, and preliminary effectiveness. The trial aims to gather data on the pharmacokinetics and immunogenicity of the treatment regimen in subjects with unresectable or metastatic melanoma.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willingness to provide written informed consent and follow the study treatment plan and visit plan;
2. Aged ≥ 18 years at time of signing informed consent, male or female;
3. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
4. Have life expectancy of at least 12 weeks ;
5. Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1).

Exclusion criteria:

1. Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription;
2. Subjects with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required);
3. Have received major surgery within 4 weeks before the first administration;
4. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);
5. Women during pregnancy or lactation;

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Union Hospital Tongji Medical College Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting
• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• Jilin Cancer Hospital
  Changchun, Jilin, China Recruiting

Study contacts

• Principal investigator: Jun Guo, Prof — Peking University Cancer Hospital & Institute
• Study coordinator: Xiangyu Ma
• Email: maxy@leadsbiolabs.com
• Phone: 025-83378099-828

Similar studies

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

• 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

• Pre-surgery targeted artery embolization plus toripalimab and axitinib for advanced kidney cancer

  This test tries a targeted artery embolization one week before starting toripalimab plus axitinib to shrink advanced kidney tumors and improve outcomes for people preparing for surgery.

  Recruiting Phase 2 Tianjin Medical University Second Hospital · Tianjin, Tianjin Municipality · NCT07172386

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

  This research will test whether LBL-024, given alone or with LBL-007 or with the PD-1 drug toripalimab, helps people with advanced melanoma.

  Recruiting at 10 sites Phase 1/2 Nanjing Leads Biolabs Co.,Ltd · Beijing, Beijing Municipality and 15 other locations · NCT07099430

• Combining radiation therapy with targeted and immunotherapy for advanced kidney cancer

  This study is testing a new treatment that combines radiation therapy with two other medications to see if it helps people with advanced kidney cancer live longer without their disease getting worse.

  Recruiting Phase 2 Peking University First Hospital · Beijing, Beijing Municipality · NCT06889649

• Postoperative treatment for high-risk non-clear renal cell carcinoma

  This study is testing if a combination of two medications can help prevent the return of non-clear renal cell carcinoma in patients who have just had surgery to remove their tumor.

  Recruiting at 2 sites Phase 2 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu and 1 other locations · NCT05768464

• 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

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.