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

Primary Purpose

T-cell Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CPI-818
Sponsored by
Corvus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-cell Lymphoma focused on measuring CTCL, PTCL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford UniversityRecruiting
  • University of MichiganRecruiting
  • Washington UniversityRecruiting
  • Hackensack University Medical CenterRecruiting
  • Ohio State UniversityRecruiting
  • University of PittsburghRecruiting
  • Concord Repatriation General HospitalRecruiting
  • Liverpool HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • Epworth HealthcareRecruiting
  • Beijing Friendship HospitalRecruiting
  • Beijing Boren HospitalRecruiting
  • Beijing Cancer HospitalRecruiting
  • Shanghai East HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul St. Mary's HospitalRecruiting
  • Inje University Busan-Paik HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Gachon UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CPI-818 Dose Escalation

CPI-818 Dose Expansion phase

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818
Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818
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
Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.
Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.

Full Information

First Posted
May 7, 2019
Last Updated
June 20, 2022
Sponsor
Corvus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03952078
Brief Title
A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2019 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corvus Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-cell Lymphoma
Keywords
CTCL, PTCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
151 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPI-818 Dose Escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
CPI-818 Dose Expansion phase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CPI-818
Intervention Description
Interleukin-2 inducible T-cell Kinase Inhibitor
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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.
Title
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.
Title
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
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director Clinical Operations
Phone
650-900-4548
Email
inquiry@corvuspharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suresh Mahabhashyam, MD, MPH
Organizational Affiliation
Corvus Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
650-900-4562
Email
amohammady@corvuspharma.com
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
650-900-4562
Email
amohammady@corvuspharma.com
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
650-900-4562
Email
amohammady@corvuspharma.com
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
650-900-4562
Email
amohammady@corvuspharma.com
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
650-900-4562
Email
amohammady@corvuspharma.com
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
650-900-4562
Email
amohammady@corvuspharma.com
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Epworth Healthcare
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Beijing Boren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Shanghai East Hospital
City
Pudong
State/Province
Shanghai
ZIP/Postal Code
200136
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Henan Cancer Hospital
City
Henan
State/Province
Zhengzhou
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Gyeonggido
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Asan Medical Center
City
Seoul
State/Province
Gyeonggido
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gyeonggido
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Seoul St. Mary's Hospital
City
Seoul
State/Province
Gyeonggido
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Inje University Busan-Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com
Facility Name
Gachon University
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahita Mohammady
Phone
6509004562
Email
amohammady@corvuspharma.com

12. IPD Sharing Statement

Learn more about this trial

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

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