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

Official title

An Open-label, Multicenter Phase Ib/II Clinical 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

Overview

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.

Detailed description

This trial includes two phases, Phase Ib and Phase II.

Phase Ib is an exploratory stage of safety and efficacy in a single-arm, open-label study, including three cohorts (different dosing regimens).Phase Ib includes three cohorts, Cohort 1 (LBL-024 monotherapy), Cohort 2 (LBL-024 + LBL-007 combination) and Cohort 3 (LBL-024 + toripalimab combination).

Phase II includes Part A and Part B.Part A is a randomized, open-label, positive-controlled extension study. It plans to enroll patients with melanoma of the cutaneous, Acral, and unknown primary. Eligible subjects will be randomly assigned in a 2:1 ratio \[Stratification factor: Acral subtype (Yes vs. No)\] to either the Experimental Group or the Control Group. Part B is a single-arm extension study enrolling only patients with mucosal melanoma,and will select a drug combination based on phase Ib efficacy for expansion study.

This study requires subjects to provide relevant samples for testing. The trial will enroll up to 200 subjects.

Interventions

• Drug LBL-024 for Injection
  LBL-024 , Intravenous infusion.
• Drug LBL-007 Injection
  LBL-007 , intravenous infusion.
• Drug Toripalimab Injection
  Toripalimab , intravenous infusion.

Primary outcome measures

• Occurrence of adverse event (AE) and serious adverse event (SAE) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Objective Response Rate (ORR) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Progression-free Survival(PFS) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Secondary outcome measures (5)

• Cmax [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Tmax [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Immunogenicity [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Disease Control Rate(DCR) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Duration of Response(DOR) [Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Eligibility criteria

Inclusion criteria

• 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.
• According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours）, the subjects enrolled have at least one measurable neoplasm lesion.
• 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

• 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.
• Active infectious disease.
• History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
• Women during pregnancy or lactation.
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 15 centers

• Fujian Cancer Hospital — Fuzhou
• Sun Yat-sen University Cancer Center — Guangzhou
• Dermatology Hospital of Southern Medical University — Guangzhou
• Guangxi Medical University Cancer Hospital — Nanning
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
• Nanjing Drum Tower Hospital — Nanjing
• The First Hospital of Jilin University — Changchun
• Shandong Cancer Hospital — Jinan
• … and 7 more centers

Identifiers

NCT: NCT07099430 · LBL-024-CN007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗