A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT05387265
- Run by
- CytomX Therapeutics
- People needed
- 83
- Starts
- 2022-05-16
- Expected to finish
- 2025-06-04
- Last updated by the study team
- 2025-07-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- Additional inclusion criteria may apply
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
- Additional exclusion criteria may apply
Where it is running
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
- Sarah Cannon Research Institute, LLC — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States
- Virginia Cancer Specialist — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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