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Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CB-280
Placebos
Sponsored by
Calithera Biosciences, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Arginase inhibitor, CB-280

Eligibility Criteria

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

Inclusion Criteria:

  1. Written Informed Consent in accordance with federal, local, and institutional guidelines
  2. Confirmed diagnosis of cystic fibrosis
  3. Male or female subjects ≥ 18 years on the date of informed consent
  4. Percent predicted FEV1 of 40-90% at screening per Global Lung Function Initiative (GLI) equation
  5. Clinically stable with no significant changes in health status within 28 days prior to Day 1
  6. Chronic lung infection with P. aeruginosa defined as at least one positive culture in the last two years and more than 50% of cultures positive since then
  7. Stable cystic fibrosis medication regimen for at least 28 days inclusive of CFTR modulators prior to Day 1
  8. Hemoglobin > 10 g/dL at screening
  9. Glomerular filtration rate > 50 mL/min/1.73 m2 at screening
  10. Normal liver function at screening

Exclusion Criteria:

  1. History of any comorbidity that, in the opinion of the Investigator, might pose an additional risk in administering study drug to the subject or confound the results of the study
  2. Lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus)
  3. Unable to receive study medication per os (PO)
  4. Females who are pregnant, have a positive pregnancy test at screening, or are nursing (lactating)

Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • University of Arkansas for Medical Sciences
  • Long Beach Memorial Medical Center
  • University of Florida
  • The Cystic Fibrosis Institute
  • Indiana University
  • University of Kansas Medical Center
  • Johns Hopkins University
  • Boston Children's Hospital, Brigham & Women's Hospital
  • Billings Clinic
  • New York Medical College at Westchester Medical Center
  • UNC Marsico Clinical Research Center
  • University Hospitals Cleveland Medical Center
  • Hershey Medical Center Pennsylvania State University
  • Medical University of South Carolina
  • University of Utah
  • Vermont Lung Center at the University of Vermont Medical Center
  • Virginia Commonwealth University
  • University of Calgary
  • St. Pauls' Hospital
  • McGill University Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Placebo

Arm Description

CB-280 twice daily at 50 mg for 14 days

CB-280 twice daily at 100 mg for 14 days

CB-280 twice daily at 200 mg for 14 days

CB-280 twice daily at 400 mg for 14 days

Placebo twice daily for 14 days

Outcomes

Primary Outcome Measures

Determine the safety and tolerability of CB-280 in adult cystic fibrosis patients: incidence and severity of adverse event (AEs) assessed by Common Terminology Criteria for Adverse Events, version 5 (CTCAE v5.0)

Secondary Outcome Measures

Pharmacokinetics of plasma CB-280 measured by Peak Plasma Concentration (Cmax)
Pharmacokinetics of plasma CB-280 measured by area under the plasma concentration versus time curve, from time 0 to the last observed non-zero concentration (AUC 0-t)

Full Information

First Posted
February 10, 2020
Last Updated
April 11, 2022
Sponsor
Calithera Biosciences, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04279769
Brief Title
Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
Official Title
A Phase 1b Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calithera Biosciences, 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 1b multiple ascending dose escalation study to evaluate the safety and tolerability of arginase inhibitor CB-280 in subjects with cystic fibrosis.
Detailed Description
Study CX-280-202 is a Phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of CB-280 in adult subjects with cystic fibrosis and chronic infection with Pseudomonas aeruginosa. The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and biological activity of CB-280 in approximately 32 adult patients with cystic fibrosis. There are four planned sequential dose escalation cohorts of 8 subjects each, randomized 6:2 to receive CB-280 or matched placebo at doses of 50 mg, 100 mg, 200 mg, or 400 mg administered twice daily for 14 days. Intermediate dose levels may be evaluated based on emerging safety data at the planned dose levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Arginase inhibitor, CB-280

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
CB-280 twice daily at 50 mg for 14 days
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
CB-280 twice daily at 100 mg for 14 days
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
CB-280 twice daily at 200 mg for 14 days
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
CB-280 twice daily at 400 mg for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
CB-280
Intervention Description
CB-280, oral capsule administered twice daily at the assigned dose level for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo oral capsule administrated twice daily at the assigned dose level for 14 days
Primary Outcome Measure Information:
Title
Determine the safety and tolerability of CB-280 in adult cystic fibrosis patients: incidence and severity of adverse event (AEs) assessed by Common Terminology Criteria for Adverse Events, version 5 (CTCAE v5.0)
Time Frame
Start of treatment to Day 28
Secondary Outcome Measure Information:
Title
Pharmacokinetics of plasma CB-280 measured by Peak Plasma Concentration (Cmax)
Time Frame
Day 14
Title
Pharmacokinetics of plasma CB-280 measured by area under the plasma concentration versus time curve, from time 0 to the last observed non-zero concentration (AUC 0-t)
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written Informed Consent in accordance with federal, local, and institutional guidelines Confirmed diagnosis of cystic fibrosis Male or female subjects ≥ 18 years on the date of informed consent Percent predicted FEV1 of 40-90% at screening per Global Lung Function Initiative (GLI) equation Clinically stable with no significant changes in health status within 28 days prior to Day 1 Chronic lung infection with P. aeruginosa defined as at least one positive culture in the last two years and more than 50% of cultures positive since then Stable cystic fibrosis medication regimen for at least 28 days inclusive of CFTR modulators prior to Day 1 Hemoglobin > 10 g/dL at screening Glomerular filtration rate > 50 mL/min/1.73 m2 at screening Normal liver function at screening Exclusion Criteria: History of any comorbidity that, in the opinion of the Investigator, might pose an additional risk in administering study drug to the subject or confound the results of the study Lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus) Unable to receive study medication per os (PO) Females who are pregnant, have a positive pregnancy test at screening, or are nursing (lactating) Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emil T Kuriakose, MD
Organizational Affiliation
Calithera Bioscience
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
The Cystic Fibrosis Institute
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston Children's Hospital, Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
New York Medical College at Westchester Medical Center
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
UNC Marsico Clinical Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Hershey Medical Center Pennsylvania State University
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Vermont Lung Center at the University of Vermont Medical Center
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
St. Pauls' Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis

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