Study Using a Drug-device Combination Product to Determine Safety, Tolerability and Antitumor Activity for Patients With Advanced, Non-small Cell Lung Cancer

Part of paid clinical trials in Canton, Ohio.

Sponsor
Nob Hill Therapeutics, Inc.
Study ID
NCT07864584
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NHT102 — DRUG
    NHT102 is an investigational drug product, 5-Azacytidine dry powder for oral inhalation. NHT102 is administered once daily via inhalation using a novel investigational inhalation delivery system. Dosing occurs on Days 1-5 and Days 15-19 of each 28-day cycle. Multiple dose levels (7 mg to 42 mg target lung dose per treatment day) are evaluated in Part 1, selected dose levels in Part 2, and the recommended Phase 2 dose (RP2D) in Part 3.
  • DryNeb — DEVICE
    The DryNeb is a novel investigational inhalation delivery system that delivers micronized dry powder to the lungs.

Study Details

There are 3 parts to this clinical trial. The goal of this clinical trial (NHT102-001) is to learn how safe NHT102 is, what dose works best, and whether it can help treat advanced non-small cell lung cancer (NSCLC) that has come back or remained after earlier treatment and is still confined to the lung / chest region by providing targeted inhaled treatment directly to the lungs. NHT102 is a dry powder that participants breathe in through a mouthpiece using an investigational inhalation device. Doses are given at the study site by trained staff, not at home. NHT102 is taken on days 1-5 and days 15-19 of a 28-day cycle. The main questions this clinical trial aims to answer are: Part 1 (Dose Escalation): To look at up to five different increasing dose levels of NHT102 to see if they are safe and well-tolerated and if the body absorbs the medicine from the lungs. To see if up to two dose levels studied are not only safe, but also make the cancer slow its growth or lessen its spread. And to see the highest dose that is tolerated by participants. Part 2 (Dose Optimization): To further study at up to two dose levels from Part 1 and randomly assign participants in equal numbers to one of them to learn more about NHT102's safety, how well the drug is absorbed from the lungs and how well each dose level works against the NSCLC after at least 4 months. Then identify which of the two doses is chosen for further study. Part 3 (Dose Expansion): Take the dose chosen in from Part 2 and study it in more patients to continue look at the drug safety, how much of it is absorbed into the body from the lungs and if it works to stop or reduce the spread of NSCLC. Participants will: * Take NHT102 at the study site daily on days 1-5 days and days 15-19 during a 28-day cycle for as long as it is helping them and they can tolerate it. Treatment stops if the cancer worsens, if side effects become too difficult to manage, or if the participant or their doctor decides to stop. * Tell doctors and staff about all medications they are taking, any issues with their study medication and all side effects they may be having whether they are taking the medication that day or not. * Return for a safety visit about 30 days after their last dose, then receive phone calls about 3 months and 6 months later to check on their health.

Key Dates

First listed
Oct 8, 2026
Start date
Jan 11, 2027
Status verified
Oct 2026
Primary completion
Jul 13, 2029
Completion
Jul 12, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Participants receive NHT102 via inhalation once daily on Days 1-5 and Days 15-19 of each 28 day cycle. Up to five dose levels (7 mg to 42 mg target lung dose \[TLD\] per treatment day) are evaluated using a standard 3+3 design to determine dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD). Additional intermediate dose level cohorts may be added at the recommendation of the Safety Review Committee (SRC). Interventions: NHT102 (5-AZA dry powder for inhalation) DryNeb Device
  • Experimental: Dose Optimization
    Participants are randomized 1:1 to one of two dose levels selected from Part 1. Each dose level is evaluated using Simon Two Stage design to assess anti-tumor activity, safety, pharmacokinetics, pharmacodynamics, and exploratory biomarkers. Up to approximately 25 evaluable patients may be enrolled per dose level.
  • Experimental: Dose Expansion
    Participants receive NHT102 at the recommended Phase 2 dose (RP2D) determined from Part 2. This part further evaluates safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity.

Primary Outcome Measure

Incidence and Severity of Adverse Events (AEs) [ Time Frame: From first dose through 30 days after the last dose. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Gabrail Cancer Center ResearchCantonOhio44718
Carrie Smith, RN
Nashat Gabrail, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Gabrail Cancer Center Research· Canton, OH

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