NCT06462794

First In Human Study of CX-801 in Advanced Solid Tumors

An Investigational Study of CX-801 as Monotherapy and in Combination With PD1 Inhibition in Participants With Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (estimated)
• Sponsor: CytomX Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.

Detailed description

The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	CX-801	Investigational drug
DRUG	pembrolizumab	Standard of Care Therapy

Timeline

• Start date: 2024-08-28
• Primary completion: 2028-02-28
• Completion: 2029-06-30
• First posted: 2024-06-17
• Last updated: 2026-03-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study