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

NCT04640545 | Completed Phase 1

• 1 other identifier: LBL-007-CN-002
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Advanced Melanoma

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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).

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

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  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)

  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)

• Disease Control Rate(DCR)

  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)

• Steady state Area under the serum concentration versus time curve（AUCss）

  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)

• Steady state Maximum serum concentration (Cmax,ss)

  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)

Study Arms (1)

LBL-007+Toripalimab+Axitinib Tablets

EXPERIMENTAL

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

Drug: LBL-007; Drug: Toripalimab; Drug: Axitinib Tablets

Interventions

LBL-007 DRUG

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

LBL-007+Toripalimab+Axitinib Tablets

Toripalimab DRUG

Toripalimab Injection will be administered by intravenously (Q2W) .

LBL-007+Toripalimab+Axitinib Tablets

Axitinib Tablets DRUG

Axitinib Tablets On-demand administration

LBL-007+Toripalimab+Axitinib Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead

Study Sites (8)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130021, China

Location

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

toripalimab; Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jun Guo, Prof

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 23, 2020
• Study Start: May 12, 2020
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: September 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)