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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05451407
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Arms & Interventions

Arms

Experimental: TQB2618 injection combined with Toripalimab injection

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

Interventions

Drug: - TQB2618 injection

Humanized IgG4 mab targeting TIM-3

Drug: - Toripalimab injection

Monoclonal antibody against Programmed death factor receptor 1

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peking University Cancer Hospital, BeiJing, Beijing, China

Status

Recruiting

Address

Peking University Cancer Hospital

BeiJing, Beijing, 100142

Site Contact

Jun Guo

[email protected]

13911233048

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