RecruitingPhase 1Phase 2NCT06603246

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

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

Sponsor

Genentech, Inc.

Enrollment

128 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease Non-cystic Fibrosis Bronchiectasis

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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
Chronic sputum production of ≥1 teaspoon per day as reported in the sputum volume item
Ability to produce a sputum sample that is suitable for central laboratory determination of mucus percent solids and sialic acid concentration exploratory biomarker research, and biomarker assay development
Availability of a representative blood sample for exploratory biomarker research and biomarker assay development
\- Diagnosis of bronchiectasis on the basis of prior chest computed tomography (CT), involving at least 2 lobes, with at least one lobe of involvement in the right lung as assessed by the investigator
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

Exclusion Criteria20

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 milliliter (mL) within 3 months prior to screening
Known immunodeficiency that, in the investigator's judgment, is clinically significant and places the individual at a substantially elevated risk for opportunistic infections.
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
Diagnosis of asthma, that in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary asthma with incidental bronchiectasis findings)
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.
\- Diagnosis of COPD that, in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary COPD with incidental bronchiectasis findings)
COPD exacerbation within 28 days prior to screening or that has not returned to baseline
Asthma/COPD overlap syndrome