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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
CX-904 is a T-cell engaging bispecific Probody® candidate against Epidermal Growth Factor Receptor (EGFR) and CD3.
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
Patients Experiencing Dose-limiting Toxicity
The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol at any dose level during dose escalation.
Time frame: 12 months
Objective Response Rate (ORR)
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 Investigator assessment.
Time frame: 30 months
Duration of Response (DOR)
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.
Time frame: 30 months
Investigator-assessed Progression-Free Survival (PFS)
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.
Time frame: 30 months
Disease Control Rate (DCR)
DCR is defined as the rate of confirmed CR, PR, and stable disease (SD) as per RECIST v1.1.
Time frame: 30 months
Overall Survival (OS)
The time from treatment initiation until death due to any cause.
Time frame: 30 months
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Virginia Cancer Specialist
Fairfax, Virginia, United States