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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: TQB2618 injection; Drug: Toripalimab injection

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jun Guo, Doctor; Phone Number: 13911233048; Email: guoj307@126.com
• Study Contact Backup: Name: SiMing Li, Doctor; Phone Number: 13601308525

Study Locations

• China
  • Beijing
    • BeiJing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital
      • Contact: Jun Guo; Phone Number: 13911233048; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: TQB2618-Ib-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No