A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors

Solid Tumors Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387265
• Other study ID #: CTMX-904-101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 22, 2022
• Est. completion date: August 2025

Study information

• Verified date: June 2024
• Source: CytomX Therapeutics
• Contact: Karen Deane
• Phone: (650) 515-3185
• Email: ClinicalTrials[@]CytomX.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 including

• History of or current active autoimmune diseases

• History of myocarditis regardless of the cause

• Pregnant or breast feeding

• Additional exclusion criteria may apply

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
United States	Sarah Cannon Research Institute at HealthONE	Denver	Colorado
United States	Virginia Cancer Specialist	Fairfax	Virginia
United States	MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute, LLC	Nashville	Tennessee
United States	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CytomX Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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 Central Radiology Review (CRR).	30 months
Secondary	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.	30 months
Secondary	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.	30 months
Secondary	Disease Control Rate (DCR)	DCR is defined as the rate of confirmed CR, PR, and stable disease (SD) as per RECIST v1.1.	30 months
Secondary	Overall Survival (OS)	The time from treatment initiation until death due to any cause.	30 months