NCT03149549

PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: CytomX Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001 PROBODY is a trademark of CytomX Therapeutics, Inc

Conditions

• Solid Tumor, Adult
• Breast Cancer
• Non Small Cell Lung Cancer
• Head and Neck Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	CX-2009	CX-2009 Monotherapy

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-09-10
• Completion: 2020-09-10
• First posted: 2017-05-11
• Last updated: 2024-01-05
• Results posted: 2024-01-05

Locations

26 sites across 4 countries: United States, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study