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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 : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
Clarametyx Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE November 29, 2023
First Posted Date  ICMJE December 7, 2023
Last Update Posted Date May 9, 2024
Actual Study Start Date  ICMJE January 17, 2024
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2023)
  • Number and % of participants experiencing adverse events following a single IV infusion of CMTX-101 [ Time Frame: Day 1 to Day 28 ]
    Primary objective
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2023)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis
Official Title  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Persistent Infection
  • Cystic Fibrosis
Intervention  ICMJE
  • Drug: CMTX-101
    CMTX-101 is a humanized monoclonal antibody administered as a single IV infusion over approximately 60 minutes.
  • Drug: Placebo
    Placebo is normal saline administered as a single IV infusion over approximately 60 minutes.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching placebo, 100mL normal saline
    Intervention: Drug: Placebo
  • Experimental: 5 mg/kg CMTX-101
    5mg/kg CMTX-101 in 100mL normal saline
    Intervention: Drug: CMTX-101
  • Experimental: 30 mg/kg CMTX-101
    30 mg/kg CMTX-101 in 100mL normal saline
    Intervention: Drug: CMTX-101
  • Experimental: 15 mg/kg CMTX-101
    15 mg/kg CMTX-101 in 100mL normal saline
    Intervention: Drug: CMTX-101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2023)
41
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Teresa Byrne 4844677678 tbyrne@clarametyx.com
Contact: Veronica Hall 6146862689 ext 5 vhall@clarametyx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06159725
Other Study ID Numbers  ICMJE CMTX101-P1-CT002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Clarametyx Biosciences, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Clarametyx Biosciences, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Clarametyx Biosciences, Inc.
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP