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

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CytomX Therapeutics

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic or locally advanced unresectable solid tumor. Must have received prior standard therapy.

• Measurable disease per RECIST 1.1

• Patients with brain metastases that are ≤ 1 cm, are symptomatic, and require treatment may be eligible after discussion with Medical Monitor.

• 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