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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 : February 28, 2023
Information provided by (Responsible Party):
CytomX Therapeutics

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: CX-904 Early Phase 1

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 a 3+3 design. Escalating dose increments will be determined in discussion with a Safety Review Committee.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: CX-904 Drug: CX-904
CX-904 is a T-cell engaging bispecific Probody® candidate against Epidermal Growth Factor Receptor (EGFR) and CD3.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. Overall Survival (OS) [ Time Frame: 30 months ]
    The time from treatment initiation until death due to any cause.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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

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Contact: Justin Ney (650) 515-3185 ClinicalTrials@CytomX.com

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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
Sponsors and Collaborators
CytomX Therapeutics
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Study Director: Monika Vainorius, M.D. CytomX Therapeutics, Inc
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Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT05387265    
Other Study ID Numbers: CTMX-904-101
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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