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)
Overview
- Phase
- Phase 1
- Intervention
- CX-904
- Conditions
- Solid Tumors
- Sponsor
- CytomX Therapeutics
- Enrollment
- 83
- Locations
- 5
- Primary Endpoint
- Patients Experiencing Dose-limiting Toxicity
- Status
- Terminated
- Last Updated
- 9 months ago
Overview
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.
Investigators
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-
- •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
Arms & Interventions
CX-904
Intervention: CX-904
Outcomes
Primary Outcomes
Patients Experiencing Dose-limiting Toxicity
Time Frame: 12 months
The number of patients experiencing a dose-limiting toxicity (DLT) as defined in the protocol at any dose level during dose escalation.
Secondary Outcomes
- Objective Response Rate (ORR)(30 months)
- Duration of Response (DOR)(30 months)
- Investigator-assessed Progression-Free Survival (PFS)(30 months)
- Disease Control Rate (DCR)(30 months)
- Overall Survival (OS)(30 months)