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

  • STATUS
    Recruiting
  • End date
    Apr 20, 2023
  • participants needed
    88
  • sponsor
    Nanjing Leads Biolabs Co.,Ltd
Updated on 18 May 2022

Summary

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

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

Details
Condition Advanced Melanoma
Treatment Toripalimab, LBL-007, Axitinib Tablets
Clinical Study IdentifierNCT04640545
SponsorNanjing Leads Biolabs Co.,Ltd
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription
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)
Have received major surgery within 4 weeks before the first administration
Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding)
Women during pregnancy or lactation
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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