Clinical trial NCT05451407: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: Initial administration up to 21 days
measure: phase II recommended dose
timeFrame: At the end of phase I, 1 subject received the first dose up to 21 days
measure: objective response rate
timeFrame: Baseline up to 96weeks
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: disease progression before death,no more than 100 months
measure: Disease Control Rate
timeFrame: Baseline up to 96 weeks
measure: Overall Survival
timeFrame: No more than 100 months from the beginning of the first dose to death
Other outcomes:
Locations:
city: BeiJing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References: