Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 4:26 AM
Study NCT ID:
NCT05148533
Status:
TERMINATED
Last Update Posted:
2024-04-15
First Post:
2021-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor
Sponsor:
TJ Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I/II Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of TJ011133 in Combination With Toripalimab in Subjects With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company Development strategy adjustment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a phase I/II study of single drug TJ011133 and Toripalimab combine treatment forAdvanced solid tumor. This study include two stages. First stage is dose escalation and second stage is dose extension. The purpose of part A is to comfirm the MTD or MED and the clinical dose. The purpose of part B is to observe the safty, effectiveness, PK, PD and biomarker properties for effective subjects.
Detailed Description:
This is an open-label, multi-center phase I/II clinical trial which will enroll 96 to 102 subjects with advanced solid tumors.
This study consists of two phases, the first of which is the dose escalation study of TJ011133 in combination with toripalimab, and the second stage is a dose expansion study.
In phase 1, approximately 3 to 6 subjects will be enrolled in each group to receive TJ011133 (30 mg/kg, 45 mg/kg, QW) in combination with toripalimab injection (240 mg, Q3W). A safety assessment committee, consisting of the sponsor and the investigator, will assess the safety of the first 3 subjects at day 21 after the first dose to determine the safety of the doses as well as to determine whether to enroll 3 additional patients to continue to evaluate the safety.
In the dose expansion phase, patients with melanoma, gastric cancer, and head and neck squamous cell carcinoma will be enrolled, with 30 patients for each malignancy, with a total of 90 patients. TJ011133 will be administered at a prespecified dose of 30 mg/kg or 45 mg/kg, QW or at a less frequency of Q2W or Q3W, and the dosing regimen will be determined based on the safety data obtained by PK/PD model analysis from other TJ011133 clinical studies. And TJ011133 will be given in combination with toripalimab injection at 240 mg, Q3W, until the occurrence of endpoint events such as intolerance or progressive disease.
This study consists of two phases, the first of which is the dose escalation study of TJ011133 in combination with toripalimab, and the second stage is a dose expansion study.
In phase 1, approximately 3 to 6 subjects will be enrolled in each group to receive TJ011133 (30 mg/kg, 45 mg/kg, QW) in combination with toripalimab injection (240 mg, Q3W). A safety assessment committee, consisting of the sponsor and the investigator, will assess the safety of the first 3 subjects at day 21 after the first dose to determine the safety of the doses as well as to determine whether to enroll 3 additional patients to continue to evaluate the safety.
In the dose expansion phase, patients with melanoma, gastric cancer, and head and neck squamous cell carcinoma will be enrolled, with 30 patients for each malignancy, with a total of 90 patients. TJ011133 will be administered at a prespecified dose of 30 mg/kg or 45 mg/kg, QW or at a less frequency of Q2W or Q3W, and the dosing regimen will be determined based on the safety data obtained by PK/PD model analysis from other TJ011133 clinical studies. And TJ011133 will be given in combination with toripalimab injection at 240 mg, Q3W, until the occurrence of endpoint events such as intolerance or progressive disease.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: