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

Phase 1Active Not RecruitingNCT03952078

Corvus Pharmaceuticals, Inc.151 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

151

Conditions

T-cell Lymphoma

Interventions

CPI-818DRUG

Interleukin-2 inducible T-cell Kinase Inhibitor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose

Time frame: First dose until 30 days after treatment stop

Incidence and nature of dose limiting toxicities (DLTs) of CPI 818 to establish either the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of CPI 818

Time frame: Up to approximately 21 days after first dose

Secondary Outcomes

Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818

Time frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.

Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818

Time frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.

Objective response rate per Laguno Classification for CTCL and Consensus Statement for Response for CTCL to assess the anti-tumor activity of CPI 818 in subjects with R/R T cell lymphoma

Time frame: From start of treatment through end of study treatment, up to approximately 24 months

Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.

Time frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.

Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.

Time frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.

Data from ClinicalTrials.gov

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