A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05387265|
Recruitment Status : Recruiting
First Posted : May 24, 2022
Last Update Posted : February 28, 2023
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histologically confirmed metastatic or locally advanced unresectable solid tumor. Must have received prior standard therapy.
- Measurable disease per RECIST 1.1
- Patients with brain metastases that are ≤ 1 cm, are symptomatic, and require treatment may be eligible after discussion with Medical Monitor.
- 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
- 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 including
- History of or current active autoimmune diseases
- History of myocarditis regardless of the cause
- Pregnant or breast feeding
- Additional exclusion criteria may apply
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|
|United States, Texas|
|MD Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|South Texas Accelerated Research Therapeutics, LLC||Recruiting|
|San Antonio, Texas, United States, 78229|
|Study Director:||Monika Vainorius, M.D.||CytomX Therapeutics, Inc|
|Responsible Party:||CytomX Therapeutics|
|Other Study ID Numbers:||
|First Posted:||May 24, 2022 Key Record Dates|
|Last Update Posted:||February 28, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|