A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma

Last updated: January 14, 2025
Sponsor: Nanjing Leads Biolabs Co.,Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Melanoma

Metastatic Melanoma

Treatment

Toripalimab

Axitinib Tablets

LBL-007

Clinical Study ID

NCT04640545
LBL-007-CN-002
  • Ages > 18
  • All Genders

Study Summary

A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Willingness to provide written informed consent and follow the study treatment planand 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 evaluationstandard of solid tumor efficacy (RECIST 1.1).

Exclusion

Exclusion criteria:

  1. Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in theprescription;

  2. Subjects with active central nervous system metastases (regardless of whether theyhave received treatment), including symptomatic brain metastases, meningealmetastases, or spinal cord compression, but asymptomatic brain metastases (noprogression and/or at least 4 weeks after radiotherapy) No neurological symptoms orsigns after surgical resection, and dexamethasone or mannitol treatment is notrequired);

  3. Have received major surgery within 4 weeks before the first administration;

  4. Subjects can not tolerate intravenous administration and have difficulty in venousblood collection (if there is a history of fainting needles and bleeding);

  5. Women during pregnancy or lactation;

Study Design

Total Participants: 88
Treatment Group(s): 3
Primary Treatment: Toripalimab
Phase: 1
Study Start date:
May 12, 2020
Estimated Completion Date:
December 20, 2025

Study Description

This trial is a multi-center, single-arm, open-label, dose-escalation and expansion phase I study of LBL-007 combined with Toripalimab and Axitinib in the treatment of unresectable or metastatic melanoma.

It is divided into Study Part A and Study Part B. The safety, tolerability, kinetic characteristics, immunogenicity and preliminary efficacy of the subjects were evaluated. Both study part A and study part B are studied in two phases: dose escalation and dose expansion

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350000
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410006
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • the First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

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