Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma

Melanoma Clinical Trial

Official title:

Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05451407
• Other study ID #: TQB2618-Ib-01
• Status: Recruiting
• Phase: Phase 1
• Start date: August 9, 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Jun Guo, Doctor
• Phone: 13911233048
• Email: guoj307[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• TQB2618 injection
Humanized IgG4 mab targeting TIM-3
• Toripalimab injection
Monoclonal antibody against Programmed death factor receptor 1

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity	Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose	Initial administration up to 21 days
Primary	phase II recommended dose	Optimal tolerated dose determined after the end of phase 1	At the end of phase I, 1 subject received the first dose up to 21 days
Primary	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)	Baseline up to 96weeks
Secondary	Progression-Free Survival	The time between the onset of first medication and disease progression (PD) or death before PD	disease progression before death,no more than 100 months
Secondary	Disease Control Rate	The ratio of disease control cases (Partial Remission+Complete Response+Partial Remission ) to total cases was calculated	Baseline up to 96 weeks
Secondary	Overall Survival	From the time of the patient's first treatment to the time of death from any cause	No more than 100 months from the beginning of the first dose to death