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

NCT ID: NCT05451407

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2023-12-31

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2618 injection combined with Toripalimab injection

TQB2618 injection combined with Toripalimab injection，21 days as a treatment cycle.

Group Type: EXPERIMENTAL

TQB2618 injection

Intervention Type: DRUG

Humanized IgG4 mab targeting TIM-3

Toripalimab injection

Intervention Type: DRUG

Monoclonal antibody against Programmed death factor receptor 1

Interventions

TQB2618 injection

Humanized IgG4 mab targeting TIM-3

Intervention Type: DRUG

Toripalimab injection

Monoclonal antibody against Programmed death factor receptor 1

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Guo, Doctor

Role: CONTACT

guoj307@126.com

13911233048

SiMing Li, Doctor

Role: CONTACT

13601308525

Facility Contacts

Jun Guo

Role: primary

guoj307@126.com

13911233048

Other Identifiers

TQB2618-Ib-01

Identifier Type: -

Identifier Source: org_study_id