A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
- Registration Number
- NCT03952078
- Lead Sponsor
- Corvus Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 151
- Adult subjects age β₯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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CPI-818 Dose Expansion phase CPI-818 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. CPI-818 Dose Escalation CPI-818 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. 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. 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. 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
Trial Locations
- Locations (22)
Seoul St. Mary's Hospital
π°π·Seoul, Gyeonggido, Korea, Republic of
University of Pittsburgh
πΊπΈPittsburgh, Pennsylvania, United States
Epworth Healthcare
π¦πΊMelbourne, Victoria, Australia
Stanford University
πΊπΈPalo Alto, California, United States
Washington University
πΊπΈSaint Louis, Missouri, United States
University of Michigan
πΊπΈAnn Arbor, Michigan, United States
Hackensack University Medical Center
πΊπΈHackensack, New Jersey, United States
Liverpool Hospital
π¦πΊLiverpool, New South Wales, Australia
Concord Repatriation General Hospital
π¦πΊConcord, New South Wales, Australia
Ohio State University
πΊπΈColumbus, Ohio, United States
Royal Adelaide Hospital
π¦πΊAdelaide, South Australia, Australia
Beijing Friendship Hospital
π¨π³Beijing, Beijing, China
Beijing Boren Hospital
π¨π³Beijing, Beijing, China
Beijing Cancer Hospital
π¨π³Beijing, Beijing, China
Shanghai East Hospital
π¨π³Pudong, Shanghai, China
Seoul National University Hospital
π°π·Seoul, Gyeonggido, Korea, Republic of
Asan Medical Center
π°π·Seoul, Gyeonggido, Korea, Republic of
Henan Cancer Hospital
π¨π³Henan, Zhengzhou, China
Samsung Medical Center
π°π·Seoul, Gyeonggido, Korea, Republic of
Pusan National University Hospital
π°π·Busan, Korea, Republic of
Gachon University
π°π·Incheon, Korea, Republic of
Inje University Busan-Paik Hospital
π°π·Busan, Korea, Republic of