NCT05451407

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

August 9, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

June 21, 2022

Last Update Submit

July 5, 2023

Conditions

Melanoma

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

Secondary Outcomes (3)

  • Progression-Free Survival

    disease progression before death,no more than 100 months

  • Disease Control Rate

    Baseline up to 96 weeks

  • Overall Survival

    No more than 100 months from the beginning of the first dose to death

Study Arms (1)

TQB2618 injection combined with Toripalimab injection

EXPERIMENTAL

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

Drug: TQB2618 injectionDrug: Toripalimab injection

Interventions

TQB2618 injectionDRUG

Humanized IgG4 mab targeting TIM-3

TQB2618 injection combined with Toripalimab injection
Toripalimab injectionDRUG

Monoclonal antibody against Programmed death factor receptor 1

TQB2618 injection combined with Toripalimab injection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-75 years old;ECOG PS score: 0\~1;The expected survival is over 3 months
  • Patients with advanced melanoma diagnosed histologically and/or cytologically
  • At least one measurable lesion was confirmed according to RECIST 1.1 criteria
  • Major organs are functioning normally
  • 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

You may not qualify if:

  • Present or present with other malignant tumors within 3 years prior to first use
  • Unalleviated toxicity above CTCAE grade 1 due to any prior treatment
  • Major surgical treatment and significant traumatic injury were performed within 28 days prior to initial administration
  • A wound or fracture that has not healed for a long time
  • Those who have a history of psychotropic drug abuse and can't get rid of it or have mental disorders
  • Subject with any severe and/or uncontrolled disease
  • 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
  • Those who have participated in and used other antitumor clinical trials within 4 weeks prior to the first drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Jun Guo, Doctor

CONTACT

13911233048guoj307@126.com

SiMing Li, Doctor

CONTACT

13601308525

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2022

First Posted

July 11, 2022

Study Start

August 9, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

July 7, 2023

Record last verified: 2022-07

Locations

CN(1)