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

NCT06159725 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CMTX101-P1-CT002
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 23

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)

Conditions

Persistent Infection; Cystic Fibrosis

Keywords

Pseudamonas auriginosa

Outcome Measures

Primary Outcomes (2)

• Number and % of participants experiencing adverse events following a single IV infusion of CMTX-101

  Primary objective

  Day 1 to Day 28

• Number and % of participants experiencing serious adverse events following a single IV infusion of CMTX-101

  Primary objective

  Day 1 to Day 28

Secondary Outcomes (9)

• Assess the CMax - observed maximum plasma concentration determined by ELISA following a single IV infustion of CMTX-101

  Day 1 to Day 35

• Assess the TMax - time to reach maximum concentration curve following a single IV infusion of CMTX-101

  Day 1 to Day 35

• Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following a single IV infusion of CMTX-101

  Day 1 to Day 35

• Assess the Terminal phase elimination rate determined by ELISA following a single IV infusion of CMTX-101

  Day 1 to Day 35

• Assess the Terminal elimination half- determined by ELISA following a single IV infusion of CMTX-101

  Day 1 to Day 35

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Matching placebo, 100mL normal saline

Drug: Placebo

5 mg/kg CMTX-101

EXPERIMENTAL

5mg/kg CMTX-101 in 100mL normal saline

Drug: CMTX-101

30 mg/kg CMTX-101

EXPERIMENTAL

30 mg/kg CMTX-101 in 100mL normal saline

Drug: CMTX-101

15 mg/kg CMTX-101

EXPERIMENTAL

15 mg/kg CMTX-101 in 100mL normal saline

Drug: CMTX-101

Interventions

CMTX-101 DRUG

CMTX-101 is a humanized monoclonal antibody administered as a single IV infusion over approximately 60 minutes.

15 mg/kg CMTX-101; 30 mg/kg CMTX-101; 5 mg/kg CMTX-101

Placebo DRUG

Placebo is normal saline administered as a single IV infusion over approximately 60 minutes.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age at the time of screening.
• If enrolled in the CFF Patient Registry, must provide registry information.
• Confirmed CF diagnosis based on current CF Foundation (CFF)-sponsored guidelines.
• For participants on modulator therapy, they must be on a stable dose of modulator therapy for at least 3 months.
• Willing and capable of providing induced sputum for evaluation at defined study timepoints.
• Positive P. aeruginosa growth of ≥104 CFU/gram from a sample of induced sputum at the screening visit.
• FEV1 ≥50% (Part1) or ≥35% (Part 2) of predicted normal value at screening.
• Currently receiving inhaled antibiotic therapy, either tobramycin or aztreonam alone, or as part of CAT. At least one 28-day cycle completed within 8 weeks prior to screening visit.
• 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).
• 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.
• \- Males with infertility documentation are not required to use contraception.
• Male participants must agree to abstain from sperm donation through 4 months after study drug administration.
• Capable of providing informed consent.

You may not qualify if:

• Body mass index (BMI) \<14 at screening and baseline.
• Has a known history or evidence of human immunodeficiency virus (HIV) infection or chronic hepatitis B screening.
• Tests positive for hepatitis C virus (HCV) RNA at screening.
• Pulmonary exacerbation within 28 days of baseline.
• Requirement for continuous (24 hour/day) oxygen supplementation; periodic use is permitted.
• Participation in smoking or vaping activity in the last 6 months.
• History of, or planned, organ transplantation.
• Elevated liver function tests obtained at screening.
• ALT \>5 × ULN or AST \>5 × ULN, or
• 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.
• Greater than 5 ml of hemoptysis on one occasion or \>30 mL of hemoptysis in a 24-hour period within 28 days of baseline.
• 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.
• 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.
• Women who are pregnant, planning to become pregnant during the study period or for 4 months following last infusion of study drug, or breastfeeding.
• Active treatment of any mycobacterial or fungal organisms ≤30 days prior to baseline visit. Chronic treatment for suppression of fungal populations is allowable.

Sponsors & Collaborators

• Clarametyx Biosciences, Inc.: lead

Study Sites (23)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California, San Francisco

San Franciso, California, 94143, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803, United States

Location

St Luke's Sleep Medicine and Research Center

Boise, Idaho, 83702, United States

Location

Cystic Fibrosis Institute

Northfield, Illinois, 60093, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

New York Medical College

Hawthorne, New York, 10532, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

PennState Health

Hershey, Pennsylvania, 17003, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Persistent Infection; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1 is unmasked/open label Part 2 is masked with matching placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 is a single-group, unblinded study Part 2 is a randomized, parallel-group, placebo-controlled, double-blind study.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: June 24, 2024
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)