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

Corvus Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: T-cell Lymphoma

Treatments: Drug: CPI-818

Study type: Interventional

Funder types: Industry

Identifiers

NCT03952078

CPI-818-001

Details and patient eligibility

About

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.

Full description

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. This trial is composed of dose escalation and dose expansion cohorts.

Enrollment: 151 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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151 participants in 2 patient groups

CPI-818 Dose Escalation

Experimental group

Description:

Participants will receive CPI-818 capsule, orally, twice per day at an assigned dose, till disease progression, complete response or remission (CR) for \>2 months or if dose determined to be unsafe.

Treatment:

Drug: CPI-818

CPI-818 Dose Expansion phase

Experimental group

Description:

Participants with different T-cell lymphoma sub-types will receive CPI-818 capsules at the specific dose selected from the Dose escalation phase of the study. CPI-818 capsules at the selected dose will be taken orally, twice per day until disease progression or CR for \> 2 months.

Treatment:

Drug: CPI-818