Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

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

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

LBL-007

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

Toripalimab

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

Axitinib Tablets

Xiangyu Ma

Ting Lv

xiangyu ma

ting lv

Jun Guo, Prof

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

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

The safety profile of LBL-007 and Toripalimab will be assessed by monitoring the adverse event(AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)v5.0

MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first two cycles.

DLT is defined as a toxicities(adverse event at least possibly related to LBL-007 and Toripalimab )occurring during the DLT observation period(the initial 28 days).

Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST v1.1. and iRECIST.

Defined as the time from earliest date of disease response (CR 、PR、iCR、iPR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1 and iRECIST, or death from any cause, if occurring sooner than progression.

Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response

To determine the PK profile of LBL-007 in combination with Toripalimab

The PD evaluation index is the LAG-3 receptor occupancy rate in peripheral blood

The immunogenicity evaluation indicators are the incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibodies (if applicable) in the subject.

Spots Global Cancer Trial Database for axitinib tablets