NCT05387265

A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors

A Phase 1/1b, Open-label, Dose-finding, First-in-human Study to Evaluate the Safety and Antitumor Activity of CX-904, an EGFR-targeted T-cell Engager in Advanced Solid Tumors (CTMX-904-101)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: CytomX Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this first-in-human study, CTMX-904-101, is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-904 in adult subjects with metastatic or locally advanced unresectable solid tumors.

Detailed description

This is a first-in-human study evaluating the safety, tolerability, and activity of CX-904, a conditionally activated T-cell bispecific to EGFR and CD3. The design includes single patient cohorts and a 3+3 design. Escalating dose increments will be determined in discussion with a Safety Review Committee.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	CX-904	CX-904 is a T-cell engaging bispecific Probody® candidate against Epidermal Growth Factor Receptor (EGFR) and CD3.

Timeline

• Start date: 2022-05-16
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2022-05-24
• Last updated: 2025-07-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study