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

CytomX

Status and phase: Terminated; Phase 1

Conditions: Solid Tumors

Treatments: Drug: CX-904

Study type: Interventional

Funder types: Industry

Identifiers

NCT05387265

CTMX-904-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

CX-904

Experimental group

Treatment:

Drug: CX-904