NCT05148533

A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: TJ Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TJ1133 Injection	TJ011133 (30 mg/kg, 45 mg/kg,QW) in combination with toripalimab injection (240 mg, Q3W)

Timeline

• Start date: 2021-12-30
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2021-12-08
• Last updated: 2024-04-15

Locations

22 sites across 1 country: China