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

Nanjing Leads Biolabs Co.,Ltd79 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Melanoma

Interventions

LBL-007DRUG

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

ToripalimabDRUG

Toripalimab Injection will be administered by intravenously (Q2W) .

Axitinib TabletsDRUG

Axitinib Tablets On-demand administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (8)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Outcomes

Primary Outcomes

Number of subjcects with adverse events and serious adverse events

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

Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

Maximum tolerated dose (MTD)

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.

Time frame: During the first two Cycles(each cycle is 14 days)

Dose-limiting toxicities (DLT)

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).

Time frame: During the first two Cycles(each cycle is 14 days)

Secondary Outcomes

Objective Response Rate (ORR)

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.

Time frame: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

Duration of Response(DOR)

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.

Data from ClinicalTrials.gov

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