Back to resultsA Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma
Primary Purpose
Advanced Melanoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LBL-007
Toripalimab
Axitinib Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Melanoma
Eligibility 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;
Sites / Locations
- Beijing Cancer HospitalRecruiting
- Fujian Cancer HospitalRecruiting
- Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
- Hunan Cancer HospitalRecruiting
- Nanjing Drum Tower HospitalRecruiting
- Jilin Cancer HospitalRecruiting
- the First Hospital of Jilin UniversityRecruiting
- West China Hospital of Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LBL-007+Toripalimab+Axitinib Tablets
Arm Description
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
Outcomes
Primary Outcome Measures
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
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.
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).
Secondary Outcome Measures
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.
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.
Disease Control Rate(DCR)
Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response
Steady state Area under the serum concentration versus time curve（AUCss）
To determine the PK profile of LBL-007 in combination with Toripalimab
Steady state Maximum serum concentration (Cmax,ss)
To determine the PK profile of LBL-007 in combination with Toripalimab
Steady state Time to reach maximum serum concentration (Tmax,ss)
To determine the PK profile of LBL-007 in combination with Toripalimab
Pharmacodynamic (PD) index
The PD evaluation index is the LAG-3 receptor occupancy rate in peripheral blood
Immunogenicity index
The immunogenicity evaluation indicators are the incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibodies (if applicable) in the subject.
Full Information
NCT ID
NCT04640545
First Posted
November 9, 2020
Last Updated
June 5, 2023
Sponsor
Nanjing Leads Biolabs Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04640545
Brief Title
A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
April 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Leads Biolabs Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LBL-007+Toripalimab+Axitinib Tablets
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
LBL-007
Intervention Description
LBL-007 will be administered intravenously every two weeks (Q2W) at doses of Dose A, Dose B, Dose C,Dose D .
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Intervention Description
Toripalimab Injection will be administered by intravenously (Q2W) by the fixed dose of 3 mg/kg .
Intervention Type
Drug
Intervention Name(s)
Axitinib Tablets
Intervention Description
Axitinib Tablets 5mg and Axitinib Tablets 1mg(On-demand administration)
Primary Outcome Measure Information:
Title
Number of subjcects with adverse events and serious adverse events
Description
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)
Title
Maximum tolerated dose (MTD)
Description
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)
Title
Dose-limiting toxicities (DLT)
Description
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 Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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)
Title
Duration of Response(DOR)
Description
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.
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)
Title
Disease Control Rate(DCR)
Description
Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response
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)
Title
Steady state Area under the serum concentration versus time curve（AUCss）
Description
To determine the PK profile of LBL-007 in combination with Toripalimab
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)
Title
Steady state Maximum serum concentration (Cmax,ss)
Description
To determine the PK profile of LBL-007 in combination with Toripalimab
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)
Title
Steady state Time to reach maximum serum concentration (Tmax,ss)
Description
To determine the PK profile of LBL-007 in combination with Toripalimab
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)
Title
Pharmacodynamic (PD) index
Description
The PD evaluation index is the LAG-3 receptor occupancy rate in peripheral blood
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)
Title
Immunogenicity index
Description
The immunogenicity evaluation indicators are the incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibodies (if applicable) in the subject.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangyu Ma
Phone
025-83378099-828
Email
maxy@leadsbiolabs.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Lv
Phone
025-83378099-829
Email
lvting@leadsbiolabs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Guo, Prof
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangyu Ma
Phone
025-83378099-828
Email
maxy@leadsbiolabs.com
First Name & Middle Initial & Last Name & Degree
Ting Lv
Phone
025-83378099-829
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiangyu ma
Phone
025-83378099
Email
maxy@leadsbiolabs.com
First Name & Middle Initial & Last Name & Degree
ting lv
Phone
025-83378099
Email
lvting@leadsbiolabs.com
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiangyu ma
Phone
02583378099
Email
maxy@leadsbiolabs.com
First Name & Middle Initial & Last Name & Degree
ting lv
Phone
02583378099
Email
lvting@leadsbiolabs.com
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangyu Ma
Phone
025-83378099-828
Email
maxy@leadsbiolabs.com
First Name & Middle Initial & Last Name & Degree
Ting Lv
Phone
025-83378099-829
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiangyu ma
Phone
025-83378099
Email
maxy@leadsbiolabs.com
First Name & Middle Initial & Last Name & Degree
ting lv
Phone
025-83378099
Email
lvting@leadsbiolabs.com
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiangyu ma
Phone
02583378099
Email
maxy@leadsbiolabs.com
First Name & Middle Initial & Last Name & Degree
ting lv
Phone
+862583378099
Email
lvting@leadsbiolabs.com
Facility Name
the First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiangyu ma
Phone
02583378099
Email
maxy@leadsbiolabs.com
First Name & Middle Initial & Last Name & Degree
ting lv
Phone
02583378099
Email
lvting@leadsbiolabs.com
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangyu Ma
Phone
025-83378099-828
Email
maxy@leadsbiolabs.com
First Name & Middle Initial & Last Name & Degree
Ting Lv
Phone
025-83378099-829
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma
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