A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
- Conditions
- Solid Tumors
- Interventions
- Drug: CX-904
- Registration Number
- NCT05387265
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CX-904 CX-904 -
- Primary Outcome Measures
Name Time Method Patients Experiencing Dose-limiting Toxicity 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
Name Time Method Investigator-assessed Progression-Free Survival (PFS) 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) 30 months DCR is defined as the rate of confirmed CR, PR, and stable disease (SD) as per RECIST v1.1.
Objective Response Rate (ORR) 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) 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.
Overall Survival (OS) 30 months The time from treatment initiation until death due to any cause.
Trial Locations
- Locations (5)
South Texas Accelerated Research Therapeutics, LLC
🇺🇸San Antonio, Texas, United States
Virginia Cancer Specialist
🇺🇸Fairfax, Virginia, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Sarah Cannon Research Institute at HealthONE
🇺🇸Denver, Colorado, United States
Sarah Cannon Research Institute, LLC
🇺🇸Nashville, Tennessee, United States