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

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ClinicalTrials.gov Identifier: NCT03952078
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
T-cell Lymphoma Drug: CPI-818 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 151 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




Primary Outcome Measures :
  1. 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 ]
  2. 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 Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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 ]
  4. 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. ]
  5. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952078


Contacts
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Contact: Director Clinical Operations 650-900-4548 inquiry@corvuspharma.com

Locations
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Australia, Western Australia
Linear Clinical Research Recruiting
Perth, Western Australia, Australia, 6065
Contact: Gabriel Luciano    +61 8 6382 5100      
Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Investigators
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Study Director: Mehrdad Mobasher, MD, MPH Corvus Pharmaceuticals

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Responsible Party: Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03952078     History of Changes
Other Study ID Numbers: CPI-818-001
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs