A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05387265|
Recruitment Status : Recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: CX-904||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||February 22, 2022|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||August 2025|
CX-904 is a T-cell engaging bispecific Probody® candidate against Epidermal Growth Factor Receptor (EGFR) and CD3.
- Patients Experiencing Dose-limiting Toxicity [ Time Frame: 12 months ]The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol at any dose level during dose escalation.
- Objective Response Rate (ORR) [ Time Frame: 30 months ]ORR is the proportion of patients in the efficacy-evaluable population with a best response of Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Central Radiology Review (CRR).
- Duration of Response (DOR) [ Time Frame: 30 months ]The time from the first documentation of CR or PR (based on RECIST v1.1) that is subsequently confirmed to the first documentation of disease progression or death due to any cause on study, whichever occurs first.
- Investigator-assessed Progression-Free Survival (PFS) [ Time Frame: 30 months ]The time from the date of the first dose of study treatment until documentation of objective tumor progression based on RECIST v1.1 or until death due to any cause, whichever occurs first.
- Disease Control Rate (DCR) [ Time Frame: 30 months ]DCR is defined as the rate of confirmed CR, PR, and stable disease (SD) as per RECIST v1.1.
- Overall Survival (OS) [ Time Frame: 30 months ]The time from treatment initiation until death due to any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05387265
|Contact: Justin Ney||(650) 515-3185||ClinicalTrials@CytomX.com|
|United States, Tennessee|
|Sarah Cannon Research Institute, LLC||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Lawrence Lu||CytomX Therapeutics, Inc|