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

NCT05387265 | Terminated Phase 1 FDA Drug

• 1 other identifier: CTMX-904-101
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Patients Experiencing Dose-limiting Toxicity

  The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol at any dose level during dose escalation.

  12 months

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  30 months

• Duration of Response (DOR)

  30 months

• Investigator-assessed Progression-Free Survival (PFS)

  30 months

• Disease Control Rate (DCR)

  30 months

• Overall Survival (OS)

  30 months

Study Arms (1)

CX-904

EXPERIMENTAL

Drug: CX-904

Interventions

CX-904 DRUG

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

CX-904

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic or locally advanced unresectable solid tumor. Must have received prior standard therapy.
• Measurable disease per RECIST 1.1
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Adequate baseline laboratory values
• Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control from signing the ICF, and for a period of 30 days after the last dose of CX-904.

You may not qualify if:

• History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator, present a low risk of recurrence
• Screening electrocardiogram demonstrating a mean QTcF value \> 480 msec; a screening echocardiogram with left ventricular ejection fraction (LVEF) \< 50%
• Serious concurrent illness
• History of or current active autoimmune diseases
• History of myocarditis regardless of the cause
• Pregnant or breast feeding

Sponsors & Collaborators

• CytomX Therapeutics: lead

Study Sites (5)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialist

Fairfax, Virginia, 22031, United States

Location

Study Officials

• Monika Vainorius, M.D.

  CytomX Therapeutics, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: May 16, 2022
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (5)