Back to resultsEfficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma
Primary Purpose
Melanoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQB2618 injection
Toripalimab injection
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
Inclusion Criteria:
- 1 Age: 18-75 years old;ECOG PS score: 0~1;The expected survival is over 3 months
- 2 Patients with advanced melanoma diagnosed histologically and/or cytologically
- 3 At least one measurable lesion was confirmed according to RECIST 1.1 criteria
- 4 Major organs are functioning normally
- 5 Female subjects of reproductive age should agree to use contraceptive methods (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study;Negative serum pregnancy/urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;Male subjects should agree to use contraception during the study and for six months after the end of the study period
Exclusion Criteria:
- 1 Present or present with other malignant tumors within 3 years prior to first use
- 2 Unalleviated toxicity above CTCAE grade 1 due to any prior treatment
- 3 Major surgical treatment and significant traumatic injury were performed within 28 days prior to initial administration
- 4 A wound or fracture that has not healed for a long time
- 5 Those who have a history of psychotropic drug abuse and can't get rid of it or have mental disorders
- 6 Subject with any severe and/or uncontrolled disease
- 7 Prior chemotherapy within 3 weeks prior to initial drug use, and prior radiotherapy or other antineoplastic drugs within 2 weeks prior to initial drug use
- 8 Those who have participated in and used other antitumor clinical trials within 4 weeks prior to the first drug use
Sites / Locations
- Peking University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TQB2618 injection combined with Toripalimab injection
Arm Description
TQB2618 injection combined with Toripalimab injection，21 days as a treatment cycle.
Outcomes
Primary Outcome Measures
Dose-limiting toxicity
Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose
phase II recommended dose
Optimal tolerated dose determined after the end of phase 1
objective response rate
The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit (at the time of the next imaging evaluation)
Secondary Outcome Measures
Progression-Free Survival
The time between the onset of first medication and disease progression (PD) or death before PD
Disease Control Rate
The ratio of disease control cases (Partial Remission+Complete Response+Partial Remission ) to total cases was calculated
Overall Survival
From the time of the patient's first treatment to the time of death from any cause
Full Information
NCT ID
NCT05451407
First Posted
June 21, 2022
Last Updated
July 5, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05451407
Brief Title
Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma
Official Title
Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group 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
This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQB2618 injection combined with Toripalimab injection
Arm Type
Experimental
Arm Description
TQB2618 injection combined with Toripalimab injection，21 days as a treatment cycle.
Intervention Type
Drug
Intervention Name(s)
TQB2618 injection
Intervention Description
Humanized IgG4 mab targeting TIM-3
Intervention Type
Drug
Intervention Name(s)
Toripalimab injection
Intervention Description
Monoclonal antibody against Programmed death factor receptor 1
Primary Outcome Measure Information:
Title
Dose-limiting toxicity
Description
Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose
Time Frame
Initial administration up to 21 days
Title
phase II recommended dose
Description
Optimal tolerated dose determined after the end of phase 1
Time Frame
At the end of phase I, 1 subject received the first dose up to 21 days
Title
objective response rate
Description
The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit (at the time of the next imaging evaluation)
Time Frame
Baseline up to 96weeks
Secondary Outcome Measure Information:
Title
Progression-Free Survival
Description
The time between the onset of first medication and disease progression (PD) or death before PD
Time Frame
disease progression before death,no more than 100 months
Title
Disease Control Rate
Description
The ratio of disease control cases (Partial Remission+Complete Response+Partial Remission ) to total cases was calculated
Time Frame
Baseline up to 96 weeks
Title
Overall Survival
Description
From the time of the patient's first treatment to the time of death from any cause
Time Frame
No more than 100 months from the beginning of the first dose to death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1 Age: 18-75 years old;ECOG PS score: 0~1;The expected survival is over 3 months
2 Patients with advanced melanoma diagnosed histologically and/or cytologically
3 At least one measurable lesion was confirmed according to RECIST 1.1 criteria
4 Major organs are functioning normally
5 Female subjects of reproductive age should agree to use contraceptive methods (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study;Negative serum pregnancy/urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;Male subjects should agree to use contraception during the study and for six months after the end of the study period
Exclusion Criteria:
1 Present or present with other malignant tumors within 3 years prior to first use
2 Unalleviated toxicity above CTCAE grade 1 due to any prior treatment
3 Major surgical treatment and significant traumatic injury were performed within 28 days prior to initial administration
4 A wound or fracture that has not healed for a long time
5 Those who have a history of psychotropic drug abuse and can't get rid of it or have mental disorders
6 Subject with any severe and/or uncontrolled disease
7 Prior chemotherapy within 3 weeks prior to initial drug use, and prior radiotherapy or other antineoplastic drugs within 2 weeks prior to initial drug use
8 Those who have participated in and used other antitumor clinical trials within 4 weeks prior to the first drug use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Guo, Doctor
Phone
13911233048
Email
guoj307@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
SiMing Li, Doctor
Phone
13601308525
Facility Information:
Facility Name
Peking University 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
Jun Guo
Phone
13911233048
Email
guoj307@126.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma
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