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A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06159725
Recruitment Status : Recruiting
First Posted : December 7, 2023
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
Clarametyx Biosciences, Inc.

Brief Summary:

CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunctive therapy to standard of care antibiotics. The goal of this clinical trial is to assess the safety and tolerability of CMTX-101 in people with cystic fibrosis (pwCF).

The main questions the study aims to answer are:

  • Are single doses of CMTX-101 IV infusion safe and tolerated
  • What is the pharmacokinetic (PK) profile of single doses of CMTX-101
  • Do single doses of CMTX-101 induce development of anti-drug antibodies (ADA) and neutralizing antibodies (Nabs)

Condition or disease Intervention/treatment Phase
Persistent Infection Cystic Fibrosis Drug: CMTX-101 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part 1 is a single-group, unblinded study Part 2 is a randomized, parallel-group, placebo-controlled, double-blind study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Part 1 is unmasked/open label Part 2 is masked with matching placebo
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Study To Evaluate The Safety Of CMTX-101 In Combination With Inhaled Tobramycin In People With Cystic Fibrosis Chronically Infected With Pseudomonas Aeruginosa
Actual Study Start Date : January 17, 2024
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo, 100mL normal saline
Drug: Placebo
Placebo is normal saline administered as a single IV infusion over approximately 60 minutes.

Experimental: 5 mg/kg CMTX-101
5mg/kg CMTX-101 in 100mL normal saline
Drug: CMTX-101
CMTX-101 is a humanized monoclonal antibody administered as a single IV infusion over approximately 60 minutes.

Experimental: 30 mg/kg CMTX-101
30 mg/kg CMTX-101 in 100mL normal saline
Drug: CMTX-101
CMTX-101 is a humanized monoclonal antibody administered as a single IV infusion over approximately 60 minutes.

Experimental: 15 mg/kg CMTX-101
15 mg/kg CMTX-101 in 100mL normal saline
Drug: CMTX-101
CMTX-101 is a humanized monoclonal antibody administered as a single IV infusion over approximately 60 minutes.




Primary Outcome Measures :
  1. Number and % of participants experiencing adverse events following a single IV infusion of CMTX-101 [ Time Frame: Day 1 to Day 28 ]
    Primary objective

  2. Number and % of participants experiencing serious adverse events following a single IV infusion of CMTX-101 [ Time Frame: Day 1 to Day 28 ]
    Primary objective


Secondary Outcome Measures :
  1. Assess the CMax - observed maximum plasma concentration determined by ELISA following a single IV infustion of CMTX-101 [ Time Frame: Day 1 to Day 35 ]
    Secondary objective

  2. Assess the TMax - time to reach maximum concentration curve following a single IV infusion of CMTX-101 [ Time Frame: Day 1 to Day 35 ]
    Secondary objective

  3. Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following a single IV infusion of CMTX-101 [ Time Frame: Day 1 to Day 35 ]
    Secondary objective

  4. Assess the Terminal phase elimination rate determined by ELISA following a single IV infusion of CMTX-101 [ Time Frame: Day 1 to Day 35 ]
    Secondary objective

  5. Assess the Terminal elimination half- determined by ELISA following a single IV infusion of CMTX-101 [ Time Frame: Day 1 to Day 35 ]
    Secondary objective

  6. Assess the Apparent total body clearance (CL/F) determined by ELISA following a single IV infusion of CMTX-101 [ Time Frame: Day 1 to Day 35 ]
    Secondary objective

  7. Assess the Apparent volume distribution (Vx/F) determined by ELISA following a single IV infustion of CMTX-101 [ Time Frame: Day 1 to Day 35 ]
    Secondary objective

  8. Evaluate the immunogenicity of CMTX-101 as measured by anti-drug antibodies (ADA) determined by the electrochemiluminescence assay following a single IV infustion of CMTX-101 [ Time Frame: Day 1 to Day 35 ]
    Secondary objective

  9. Assess the apparent reduction in pulmonary P. auriginosa burden as measured by quantitative microbial culture of sputum [ Time Frame: Day 1 to Day 28 ]
    Secondary objective



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Adults ≥18 years of age at the time of screening.
  2. Confirmed CF diagnosis based on current CF Foundation (CFF)-sponsored guidelines.
  3. For participants on modulator therapy, they must be on a stable dose of TRIKAFTA (ETI) modulator therapy for at least 3 months.
  4. Willing and capable of providing induced sputum for evaluation at defined study timepoints.
  5. Positive P. aeruginosa growth of ≥104 CFU/gram from a sample of induced sputum at the screening visit.
  6. FEV1 ≥50% (Part1) or ≥35% (Part 2) of predicted normal value at screening.
  7. Currently receiving inhaled tobramycin alone or CAT therapy. At least one 28-day cycle completed within 8 weeks prior to screening visit.

    • Note: If on CAT therapy, initiation of inhaled tobramycin should begin approximately 2 hours (±1 hour) pre-dose.

  8. Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin test during screening and agree to use an effective method of contraception for the duration of the study and for 4 months after the last infusion of study drug. A female participant is considered of childbearing potential unless postmenopausal or surgically sterilized and at least 3 months has passed since sterilization procedure. Female surgical sterilization procedures include tubal ligation, bilateral salpingectomy, hysterectomy, or bilateral oophorectomy. A female participant is considered postmenopausal if she has had spontaneous amenorrhea for at least 2 years with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms).

    • Effective methods of contraception include (a) abstinence, (b) partner vasectomy, (c) intrauterine devices, (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).

  9. Male participants with a female partner must use a medically accepted contraceptive regimen during his participation in the study and for 4 months after study drug infusion.

    • Acceptable methods of contraception for male participants include condoms with spermicide, surgical sterilization of the participant (i.e., vasectomy) at least 26 weeks before screening, or sexual abstinence (i.e., refraining from heterosexual intercourse) if that is the preferred and usual lifestyle of the participant.

  10. Male participants must agree to abstain from sperm donation through 4 months after study drug administration.
  11. Capable of providing informed consent.
  12. Capable and willing to complete all study visits and perform all procedures required by the protocol.

Exclusion Criteria:

  1. Body mass index (BMI) <14 at screening and baseline.
  2. Has a known history or evidence of human immunodeficiency virus (HIV) infection or chronic hepatitis B screening.
  3. Tests positive for hepatitis C virus (HCV) RNA at screening.
  4. Changes in underlying therapy (e.g., pulmonary massage therapy, bronchodilators, nonsteroidal anti-inflammatory drugs [NSAIDs], antibiotic agents, pancreatic enzyme preparations, nutritional supplements, and DNase) within the 21 days before, and inclusive of, study baseline or anticipated changes to underlying therapy during the study.
  5. Pulmonary exacerbation within 28 days of baseline.
  6. Requirement for continuous (24 hour/day) oxygen supplementation; periodic use is permitted.
  7. Participation in smoking or vaping activity in the last 6 months.
  8. History of, or planned, organ transplantation.
  9. Elevated liver function tests obtained at screening.

    1. ALT >5 × ULN or AST >5 × ULN, or
    2. Total bilirubin >3 × ULN or Total bilirubin >1.5 × ULN combined with either ALT >3 × ULN or AST >3 × ULN. ULN reflects local laboratory ranges.
  10. Greater than 5 ml of hemoptysis on one occasion or >30 mL of hemoptysis in a 24-hour period within 28 days of baseline.
  11. Infection with other more pathogenic organisms such as Mycobacterium abscessus or Burkholderia spp., where the investigator feels that the participant either is not or will not remain clinically stable throughout the duration of the study.
  12. Acute clinical illness requiring a new (oral, parenteral, or inhaled) antibiotic(s) ≤30 days prior to the baseline visit. Does not include chronic suppressive medications or cyclic dosing medications such as inhaled antibiotics.
  13. Women who are pregnant, planning to become pregnant during the study period or for 4 months following last infusion of study drug, or breastfeeding.
  14. Active treatment of any mycobacterial or fungal organisms ≤30 days prior to baseline visit. Chronic treatment for suppression of fungal populations is allowable.
  15. Anticipated need to change chronic (either inhaled or oral) antibiotic regimens during the study period. Participants must agree to maintain their current chronic antibiotic regimen from the screening visit for the duration of the follow-up period (approximately 30 days).
  16. Known allergy to any component of the study drug.
  17. Participant with an estimated glomerular filtration rate <60 mL/min/1.73 m2.
  18. Any significant finding that, in the opinion of the investigator, would make it unsafe for the participant to participate in this study or would not be in the best interest of the participant.
  19. Enrolled in an interventional clinical study within ≤60 days of the baseline visit, or participating in a clinical study while enrolled in this clinical study (inclusive of vaccine studies).
  20. Currently or previously enrolled in this study.

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): NCT06159725


Contacts
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Contact: Teresa Byrne 4844677678 tbyrne@clarametyx.com
Contact: Veronica Hall 6146862689 ext 5 vhall@clarametyx.com

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Megan Taylor       taylormegan@njhealth.org   
Principal Investigator: Jerry Nick, MD         
United States, Florida
Central Florida Pulmonary Group, PA Recruiting
Orlando, Florida, United States, 32803
Contact: Desiree Serr       dserr@cfpulmonary.com   
Principal Investigator: Francisco Calimano, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Monica Ulles       monica.ulles@childrens.harvard.edu   
Principal Investigator: Ryan Perkins, MD         
United States, New York
New York Medical College Recruiting
Hawthorne, New York, United States, 10532
Contact: Zachary Messer       zachary_messer@nymc.edu   
Principal Investigator: John Welter, MD         
United States, Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Cindy Schaefer       cindy.schaefer@uhhospitals.org   
Principal Investigator: Alex Gifford, MD         
United States, Pennsylvania
PennState Health Recruiting
Hershey, Pennsylvania, United States, 17003
Contact: Diane Kitch       dkitch@pennstatehealth.psu.edu   
Principal Investigator: Judie Howrylak, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Judy Jensen       judy.jensen@hsc.utah.edu   
Principal Investigator: Theodore Liou, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Ronald Gibson       ron.gibson@seattlechildrens.org   
Principal Investigator: Ronald Gibson, MD         
Sponsors and Collaborators
Clarametyx Biosciences, Inc.
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Responsible Party: Clarametyx Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT06159725    
Other Study ID Numbers: CMTX101-P1-CT002
First Posted: December 7, 2023    Key Record Dates
Last Update Posted: March 27, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clarametyx Biosciences, Inc.:
Pseudamonas auriginosa
Additional relevant MeSH terms:
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Persistent Infection
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Infections
Disease Attributes