A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Leads Biolabs Co.,Ltd

About this trial

This study is an open-label, multicenter phase Ib/II study to evaluate the efficacy and safety of LBL-024 monotherapy, LBL-024 in combination with LBL-007 or toripalimab in patients with advanced melanoma,To evaluate the preliminary efficacy and safety of LBL-024 monotherapy and combination therapy in patients with advanced melanoma.

Eligibility criteria

Qualifiers

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.

At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.

The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.

The expected survival time is at least 12 weeks.

Disqualifiers

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.

Major surgery or other treatment or diagnosis that has a significant impact on the subject within 4 weeks before the first dose.

Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.

History of severe cardiovascular and cerebrovascular disorder.

Trial design

Treatments tested in this trial

  • LBL-024 for Injection
  • LBL-007 Injection
  • Toripalimab Injection

Treatment groups

200 Participants
are divided into 3 treatment groups

Sponsors and collaborators