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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2024-08-19

Brief Summary

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

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Detailed Description

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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

Conditions

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Advanced Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LBL-007+Toripalimab+Axitinib Tablets

Study Part A： LBL-007 +Toripalimab

Study Part B： LBL-007 +Toripalimab +Axitinib Tablets

Group Type EXPERIMENTAL

LBL-007

Intervention Type DRUG

LBL-007 will be administered intravenously every two weeks (Q2W) .

Toripalimab

Intervention Type DRUG

Toripalimab Injection will be administered by intravenously (Q2W) .

Axitinib Tablets

Intervention Type DRUG

Axitinib Tablets On-demand administration

Interventions

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LBL-007

LBL-007 will be administered intravenously every two weeks (Q2W) .

Intervention Type DRUG

Toripalimab

Toripalimab Injection will be administered by intravenously (Q2W) .

Intervention Type DRUG

Axitinib Tablets

Axitinib Tablets On-demand administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription;
2. 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);
3. Have received major surgery within 4 weeks before the first administration;
4. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);
5. Women during pregnancy or lactation;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No