NCT03934814

Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma

A Phase 1 Study of TJ011133 Administered Alone or in Combination With Pembrolizumab or Rituximab in Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: I-Mab Biopharma US Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.

Detailed description

This is an open-label, multi-center, multiple dose, Phase 1 study to evaluate the safety, tolerability, maximum tolerated dose (MTD) or maximum administered dose (MAD), pharmacokinetic (PK), pharmacodynamic, and recommended Phase 2 dose (RP2D) of TJ011133, an anti-CD47 antibody, in participants with advanced relapsed or refractory solid tumors and lymphoma. The study will be conducted in 2 parts. Part 1 comprises a single agent dose escalation (Part 1A) and 2 separate combination therapy dose escalations (Part 1B with pembrolizumab and Part 1C with rituximab) and Part 2 includes a dose expansion study.

Conditions

• Solid Tumor
• Lymphoma

Interventions

Type	Name	Description
DRUG	TJ011133	TJ011133 will be administered weekly.
DRUG	Pembrolizumab	Pembrolizumab will be administered every 3 weeks.
DRUG	Rituximab	Rituximab will be administered weekly for 5 doses, then followed by monthly doses.

Timeline

• Start date: 2019-04-16
• Primary completion: 2023-01-10
• Completion: 2023-01-10
• First posted: 2019-05-02
• Last updated: 2024-07-01

Locations

21 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study