Status:
TERMINATED
A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
Lead Sponsor:
CytomX Therapeutics
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 wit...
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 ...
Eligibility Criteria
Inclusion
- 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.
- Additional inclusion criteria may apply
Exclusion
- 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
- Additional exclusion criteria may apply
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT05387265
Start Date
May 16 2022
End Date
June 4 2025
Last Update
July 14 2025
Active Locations (5)
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1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
2
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States, 37203
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229