A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
Published: April 14, 2023
Primary Outcome Measures
- Phase 1 (Dose Escalation): Incidence of adverse events [ Time Frame: From CTX131 infusion up to 28 days post-infusion ]
Defined as dose-limiting toxicities
- Phase 2 (Cohort Expansion): Objective response rate (ORR) [ Time Frame: From CTX131 infusion up to 60 months post-infusion ]
ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology
Inclusion Criteria
- Age ≥18 years.
- Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, endometrial carcinoma, and malignant pleural mesothelioma.
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Adequate renal, liver, cardiac and pulmonary organ function.
- Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX131 infusion.
Exclusion Criteria
- Prior treatment with anti-CD70 targeting agents
- History of certain central nervous system (CNS), cardiac or pulmonary conditions.
- Presence of uncontrolled bacterial, viral, or fungal infection.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Women who are pregnant or breastfeeding.