RECRUITING

A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-Obstructive Disease

Conditions

Non Cystic Fibrosis Bronchiectasis Chronic Obstructive Pulmonary Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.

Official Title

A Phase Ic, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-Obstructive Disease

Quick Facts

Study Start:2024-11-18

Study Completion:2026-02-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06603246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Percent predicted FEV1 ≥ 40% by spirometry during screening * Ability to demonstrate correct use of the Smart DPI at screening, in the investigator's judgment * On a stable treatment regimen for muco-obstructive diseases for ≥ 28 days prior to initiation of study treatment and willingness to remain on the stable treatment regimen through completion of study * Stable disease for ≥ 28 days prior to screening and through to initiation of study treatment * COPD defined as post-bronchodilator FEV1/FVC ratio of \<0.7 * Chronic bronchitis, with a definition including chronic cough and excessive sputum production for more than 3 months per year for at least 2 years prior to screening * Former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes/day for 10 years) or non-smoker with at least one documented COPD risk factor	* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the timeframe in which contraception is required * Known significant bronchodilator response of \>10% predicted change in FEV1 or FVC, in the investigator's judgment * Use of any prohibited medications * Acute respiratory infection within 28 days of screening * Significant hemoptysis greater than 60 mL within 3 months prior to screening * Known immunodeficiency including, but not limited to, human immunodeficiency virus (HIV) infection with CD4+ T cell count \<200 cells/mm\^3 or an acquired immunodeficiency syndrome (AIDS)-defining condition 6 months prior to screening * Known substance abuse, in the investigator's judgment, within 12 months prior to screening * Poor peripheral venous access * Receipt of blood products within 120 days prior to screening * Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results * History of thoracic or metastatic malignancy within 5 years prior to screening * Known history of a clinically significant abnormal electrocardiogram (ECG), or presence of an abnormal ECG that is deemed clinically significant by the investigator * QT interval corrected through use of Fridericia's formula (QTcF) \>450 milliseconds (ms) for males or \>470 ms for females * Bronchiectasis primarily due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD), in the investigator's judgment * Primary diagnosis of COPD or asthma, in the investigator's judgment * NCFB exacerbation within 28 days prior to screening or that has not returned to baseline * Current smoker: Current smoking is defined as any use of inhaled tobacco products or inhaled marijuana within 3 months prior to screening, through use of cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes. * COPD exacerbation within 28 days prior to screening or that has not returned to baseline * Asthma/COPD overlap syndrome

Inclusion Criteria

Exclusion Criteria

* Percent predicted FEV1 ≥ 40% by spirometry during screening
* Ability to demonstrate correct use of the Smart DPI at screening, in the investigator's judgment
* On a stable treatment regimen for muco-obstructive diseases for ≥ 28 days prior to initiation of study treatment and willingness to remain on the stable treatment regimen through completion of study
* Stable disease for ≥ 28 days prior to screening and through to initiation of study treatment
* COPD defined as post-bronchodilator FEV1/FVC ratio of \<0.7
* Chronic bronchitis, with a definition including chronic cough and excessive sputum production for more than 3 months per year for at least 2 years prior to screening
* Former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes/day for 10 years) or non-smoker with at least one documented COPD risk factor

* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the timeframe in which contraception is required
* Known significant bronchodilator response of \>10% predicted change in FEV1 or FVC, in the investigator's judgment
* Use of any prohibited medications
* Acute respiratory infection within 28 days of screening
* Significant hemoptysis greater than 60 mL within 3 months prior to screening
* Known immunodeficiency including, but not limited to, human immunodeficiency virus (HIV) infection with CD4+ T cell count \<200 cells/mm\^3 or an acquired immunodeficiency syndrome (AIDS)-defining condition 6 months prior to screening
* Known substance abuse, in the investigator's judgment, within 12 months prior to screening
* Poor peripheral venous access
* Receipt of blood products within 120 days prior to screening
* Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results
* History of thoracic or metastatic malignancy within 5 years prior to screening
* Known history of a clinically significant abnormal electrocardiogram (ECG), or presence of an abnormal ECG that is deemed clinically significant by the investigator
* QT interval corrected through use of Fridericia's formula (QTcF) \>450 milliseconds (ms) for males or \>470 ms for females
* Bronchiectasis primarily due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD), in the investigator's judgment
* Primary diagnosis of COPD or asthma, in the investigator's judgment
* NCFB exacerbation within 28 days prior to screening or that has not returned to baseline
* Current smoker: Current smoking is defined as any use of inhaled tobacco products or inhaled marijuana within 3 months prior to screening, through use of cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes.
* COPD exacerbation within 28 days prior to screening or that has not returned to baseline
* Asthma/COPD overlap syndrome

Contacts and Locations

Study Contact

Reference Study ID Number: GB45429 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Genentech, Inc.

Study Locations (Sites)

Accel Research Site - Achieve - Birmingham - ERN - PPDS

Vestavia Hills, Alabama, 35216-1927

United States

University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd

Kansas City, Kansas, 66160 8500

United States

TTS Research

Boerne, Texas, 78006

United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-18

Study Completion Date2026-02-27

Study Record Updates

Study Start Date2024-11-18

Study Completion Date2026-02-27

Terms related to this study

Additional Relevant MeSH Terms

Non Cystic Fibrosis Bronchiectasis
Chronic Obstructive Pulmonary Disease