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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05451407

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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 5.0 standard to evaluate the adverse events of drugs.Efficacy was evaluated using response evaluation criteria in solid tumors version 1.1 and efficacy was confirmed using response evaluation criteria in solid tumors for immune-based therapeutics criteria

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: TQB2618 injection Drug: Terprizumab injection	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TQB2618 injection combined with Terprizumab injection TQB2618 injection combined with Terprizumab injection，21 days as a treatment cycle.	Drug: TQB2618 injection Humanized IgG4 mab targeting TIM-3 Drug: Terprizumab injection Monoclonal antibody against Programmed death factor receptor 1

Arm

Intervention/Treatment

Experimental: TQB2618 injection combined with Terprizumab injection

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

Drug: TQB2618 injection

Humanized IgG4 mab targeting TIM-3

Drug: Terprizumab injection

Monoclonal antibody against Programmed death factor receptor 1

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital	BeiJing	Beijing	China	100142

Sponsors and Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05451407

Other Study ID Numbers:

TQB2618-Ib-01

First Posted:

Jul 11, 2022

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Jul 11, 2022