NCT04947033

A Study Evaluating TJ210001 in the Treatment of Subjects With Advanced Solid Tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability, MTD or MAD, PK, PD, and Antitumor Activity of TJ210001(a Fully Human C5aR Monoclonal Antibody) in Subjects With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: I-Mab Biopharma US Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase I clinical study evaluating TJ210001 in the treatment of subjects with advanced solid tumors

Detailed description

This study is a phase I clinical study evaluating TJ210001 monotherapy in patients with advanced solid tumors in dose escalation. The overall design of the study is shown in the figure below. The purpose of the TJ210001 single-dose escalation study in subjects with advanced solid tumors is to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and clinically recommended doses of TJ210001 monotherapy.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TJ210001 Injection	The test drug TJ210001 will be preset with 5 escalation dose levels: 0.3mg/kg, 1mg/kg, 3mg/kg, 10mg/kg and 15mg/kg, administered once a week.

Timeline

• Start date: 2023-12-31
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2021-07-01
• Last updated: 2023-03-14

Locations

1 site across 1 country: China