Clinical trial NCT05387265: A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: CytomX Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-05-24
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

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
* History of or current active autoimmune diseases
* History of myocarditis regardless of the cause
* Pregnant or breast feeding
* Additional exclusion criteria may apply

Primary outcomes:
measure: Patients Experiencing Dose-limiting Toxicity
timeFrame: 12 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 30 months
measure: Duration of Response (DOR)
timeFrame: 30 months
measure: Investigator-assessed Progression-Free Survival (PFS)
timeFrame: 30 months
measure: Disease Control Rate (DCR)
timeFrame: 30 months
measure: Overall Survival (OS)
timeFrame: 30 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE
state: Colorado
city: Nashville
country: United States
facility: Sarah Cannon Research Institute, LLC
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialist
state: Virginia
Study officials:
affiliation: CytomX Therapeutics, Inc
name: Monika Vainorius, M.D.
role: STUDY_DIRECTOR
References: