NCT04678921

Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors

A Phase 1 Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: I-Mab Biopharma US Limited · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD or MAD, PK, and PD of TJ210001 in subjects with relapsed or refractory advanced solid tumors. Beginning with Dose Level 1, TJ210001 will be given every week starting on Cycle 1 Day 1 (C1D1). The criteria for dose escalation/de-escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts. The BOIN design is implemented in a simple way similar to the traditional 3+3 design but is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model-based designs, such as the continual reassessment method (CRM).

Conditions

• Solid Tumor
• Metastatic Cancer
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	TJ210001	human anti-C5aR monoclonal antibody

Timeline

• Start date: 2020-12-17
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2020-12-22
• Last updated: 2022-12-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study