Trial | NCT04640545  Report issue

Title

A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma
A Phase I Multi-center Study to Evaluate the Safety ,Tolerability and Efficacy of LBL-007 Combined With Toripalimab or LBL-007 Combined With Toripalimab and Axitinib Tablets in the Treatment of Unresectable or Metastatic Melanoma

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    88
A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors
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
Study Started
May 12
2020
Primary Completion
Dec 10
2023
Anticipated
Study Completion
Apr 20
2024
Anticipated
Last Update
Jun 06
2023

Drug LBL-007

LBL-007 will be administered intravenously every two weeks (Q2W) at doses of Dose A, Dose B, Dose C,Dose D .

Drug Toripalimab

Toripalimab Injection will be administered by intravenously (Q2W) by the fixed dose of 3 mg/kg .

Drug Axitinib Tablets

Axitinib Tablets 5mg and Axitinib Tablets 1mg(On-demand administration)

LBL-007+Toripalimab+Axitinib Tablets Experimental

Study Part A： LBL-007 Dose A/Dose B/Dose C/Dose D Q2W iv+Toripalimab 3mg/kg Q2W iv； Study Part B： LBL-007 Dose A/Dose B/Dose C/Dose D Q2W iv+Toripalimab 3mg/kg Q2W iv+Axitinib Tablets 5mg + Axitinib Tablets 1mg

Criteria 

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;
No Results Posted