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

March 19, 2024 updated by: Corvus Pharmaceuticals, Inc.

A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

151

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Epworth Healthcare
  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100052
        • Beijing Friendship Hospital
      • Beijing, Beijing, China, 100142
        • Beijing Boren Hospital
    • Shanghai
      • Pudong, Shanghai, China, 200136
        • Shanghai East Hospital
    • Zhengzhou
      • Henan, Zhengzhou, China, 450003
        • Henan cancer hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 47392
        • Inje University Busan-Paik Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University
    • Gyeonggido
      • Seoul, Gyeonggido, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Gyeonggido, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Gyeonggido, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Gyeonggido, Korea, Republic of, 06591
        • Seoul st. mary's hospital
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPI-818 Dose Escalation
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.
Drug: CPI-818
Interleukin-2 inducible T-cell Kinase Inhibitor
Experimental: CPI-818 Dose Expansion phase

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.
Drug: CPI-818
Interleukin-2 inducible T-cell Kinase Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Up to approximately 21 days after first dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corvus Pharmaceuticals, Inc.

Investigators

  • Study Director: Suresh Mahabhashyam, MD, MPH, Corvus Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2019

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 16, 2019

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPI-818-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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