A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.

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

Details

• Lead Sponsor: Corvus Pharmaceuticals, Inc.
• Treatments: Interleukin-2

Criteria

Inclusion Criteria:

• Adult subjects age ≥18 years

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Histologically confirmed evidence of T-cell lymphoma

• Measurable disease.

• Adequate organ function.

• At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.

Exclusion Criteria:

• Treatment with systemic immunosuppressive medication.

• History of allogeneic hematopoietic stem cell transplantation.

• History of primary immunodeficiency, solid organ transplantation.

• History of opportunistic infection within 180 days of starting study drug.

• Females who are pregnant, lactating, or intend to become pregnant

• History of invasive prior malignancy that required systemic therapy within last 3 years.

• Concomitant use of strong inhibitors or inducers of CYP3A.