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Non-cystic Fibrosis BronchiectasisPhase 1NCT06603246

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

A Phase 1 study testing GDC-6988 in people with Non-cystic Fibrosis Bronchiectasis and Chronic Obstructive Pulmonary Disease, run by Genentech, Inc. at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
GDC-6988
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
6 sitesUnited States
Study dates
18 Nov 2024to 18 Aug 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Additional Inclusion Criteria for Participants in Part B
  • Chronic sputum production of ≥1 teaspoon per day as reported in the sputum volume item
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  • 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
  • Additional Inclusion Criteria for Participants With Non-cystic Fibrosis Bronchiectasis (NCFB) (Cohort 1, Cohort 2, and Cohort 3):
  • 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
  • Additional Inclusion Criteria for Participants With Chronic Obstructive Pulmonary Disease (COPD) (Cohort 1, Cohort 2, and Cohort 4):
  • 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

Who cannot join

  • 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.
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  • 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
  • Additional Exclusion Criteria for Participants in Part B -More than 2 chest CTs or other procedures known to expose the lungs to greater than 100 millisievert (mSv) within 12 months prior to screening
  • Additional Exclusion Criteria for Participants With NCFB (Cohort 1, Cohort 2, and Cohort 3)
  • 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.
  • Additional Exclusion Criteria for Participants with NCFB in Cohort 3
  • 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)
  • Additional Exclusion Criteria for Participants With COPD (Cohort 1, Cohort 2, and Cohort 4):
  • COPD exacerbation within 28 days prior to screening or that has not returned to baseline
  • Asthma/COPD overlap syndrome

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • TTS Research

    Boerne, Texas, 78006

  • University of North Carolina Clinical Research Center

    Chapel Hill, North Carolina, 27514

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

    Kansas City, Kansas, 66160 8500

  • Stanford Center for Excellence in Pulmonary Biology

    Palo Alto, California, 94304

  • UPMC Montefiore Hospital

    Pittsburgh, Pennsylvania, 15213 3236

Other trials in United States

About this study

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

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

Being tested
GDC-6988
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GDC-6988Drug

    Also called RO7506811

    GDC-6988 will be administered using a dry powder inhalation (DPI) device.

Study groups in NCT06603246
Study groupRoleWhat they receive
GDC-6988ExperimentalParticipants in Cohort 1 will receive low-dose GDC-6988, twice a day (BID) on Day 1, followed by high-dose, BID on Day 2. Participants in Cohort 2 will receive low-dose, followed by high-dose GDC-6988, BID for 14 days. Participants in Cohorts 3 and 4 will receive low-dose GDC-6988, BID for 14 days.
Receives: Drug: GDC-6988

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AEs), with Severity Assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grading Scale

    The AEs will be graded according to the DAIDS table for grading the severity. The severity level is graded from Grade 1 (mild) to 4 (Potentially Life-Threatening).

    Measured: From baseline up to 6 weeks

  2. Percentage of Participants With Spirometry Abnormalities

    Measured: From baseline up to 6 weeks

Secondary outcomes (6)

  1. Part A: Percentage of Participants With Spirometry Abnormalities Without and With Albuterol Pretreatment

    Spirometric abnormalities related to forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and maximal (peak) inspiratory flow rate, and flow-volume loops will be reported.

    Measured: From baseline up to 6 weeks

  2. Plasma Concentration of GDC-6988 at Specified Timepoints

    Other relevant pharmacokinetic (PK) parameters may be assessed.

    Measured: Part A: Day 1 and Day 2, Part B: Day 1, Day 8 and Day 15

  3. Part B: Change From Baseline in Sputum Percent Solids at Day 8 and Day 14

    Measured: Baseline, at Day 8 and at Day 14

  4. Part B: Change From Baseline in Whole-lung Mucociliary Clearance (MCC) Scintigraphy at Day 8

    Measured: Baseline and at Day 8

  5. Part B: Change From Baseline in Sputum Percent Solids at Day 15

    Measured: Baseline and at Day 15

  6. Part B: Change From Baseline in Whole-lung MCC Scintigraphy at Day 15

    Measured: Baseline and at Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start18 Nov 2024
  3. Primary completion18 Aug 2026
  4. Study completion18 Aug 2026

Why it stopped: Sponsor's Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06603246
Sponsor's protocol ID
GB45429
Status last verified
Oct 2026
First submitted
17 Sep 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GDC-6988 in people with Non-cystic Fibrosis Bronchiectasis and Chronic Obstructive Pulmonary Disease, run by Genentech, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor's Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs), with Severity Assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grading Scale (time frame: From baseline up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06603246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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