Sponsor Decision

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.

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