T-cell Lymphoma
Conditions
Keywords
CTCL, PTCL
Brief 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.
Detailed 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.
Interventions
DRUGCPI-818
Interleukin-2 inducible T-cell Kinase Inhibitor
Sponsors
Corvus Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose | 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 | Up to approximately 21 days after first dose |
Secondary
| Measure | Time frame |
|---|---|
| Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818 | 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. |
| Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818 | 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 | 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. | 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. | 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. |
Countries
Australia, China, South Korea, United States
Outcome results
None listed