CPI-818-001

CPI-818-001

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 T-cell lymphoma. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.

Disease:

T-Cell Lymphoma

Summary:

CPI 818 is a new tablet treatment which targets the internal machinery of the cancerous T-cell. In Western Australia the first patients in the world are being treated with this medicine and people who are eligible for this clinical trial are those with T-cell lymphoma which has persisted or come back after two different combinations of chemotherapy.

Eligibility:

Include, but not limited to, the following:

Inclusion Criteria:
1. Adult subjects age ≥18 years
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3. Histologically confirmed evidence of T-cell lymphoma
4. Measurable disease.
5. Adequate organ function.
6. 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:
1. Treatment with systemic immunosuppressive medication.
2. History of allogeneic hematopoietic stem cell transplantation.
3. History of primary immunodeficiency, solid organ transplantation.
4. History of opportunistic infection within 180 days of starting study drug.
5. Females who are pregnant, lactating, or intend to become pregnant
6. History of invasive prior malignancy that required systemic therapy within last 3 years.
7. Concomitant use of strong inhibitors or inducers of CYP3A.

Contact person:

Lewis Edwards
Email cancertrialshaem1@linear.org.au
Phone 08 9386 5125 / 08 6382 5127


Email
Phone

Principal Investigator:

Dr Dejan Radeski

08 6457 7600

Sponsor:

Corvus Pharmaceuticals, Inc.

Phase:

1b

Protocol Number:

CPI-818-001

Trial Registration Number:

NCT03952078

Clinical Trials.gov

ANZ Clinical Trial Registry