NCT03859752

TR1801-ADC in Patients With Tumors That Express c-Met

A Phase 1, Open Label, First-in-human Study of TR1801-ADC, an Antibody Drug Conjugate (ADC), in Patients With Select Solid Tumors Expressing c-Met

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Open Innovation Partners, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

First-in-human, Phase 1 study to assess safety, tolerability, and pharmacokinetics of TR1801-ADC in patients with select solid tumors that express c-Met.

Detailed description

First-in-human, Phase 1, multiple dose-dose escalation study designed to determine safety, tolerability, maximum tolerated dose, and recommended phase 2 dose of TR1801-ADC in patients with select solid tumors that express c-Met. This study will also assess pharmacokinetics (PK), anti-tumor activity, and correlation between clinical outcomes (safety, anti-tumor activity, and PK) and c-Met expression.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	TR1801-ADC	Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin

Timeline

• Start date: 2019-08-14
• Primary completion: 2023-07-04
• Completion: 2023-12-31
• First posted: 2019-03-01
• Last updated: 2023-09-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study