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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 1/2NCT07864584

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

A Phase 1/2 study testing NHT102 and DryNeb in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Nob Hill Therapeutics, Inc. at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NHT102 and DryNeb
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
11 Jan 2027to 12 Jul 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Age ≥18 years
  • Able to provide informed consent
  • Able to perform acceptable and reproducible spirometry per ATS criteria
  • Able to perform inhalation maneuver
  • Histologically or cytologically confirmed NSCLC (squamous, adenocarcinoma, or large cell undifferentiated)
  • Stage I-III NSCLC per AJCC 9th edition with recurrent or persistent thoracic confined disease
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  • Prior therapy with curative intent completed
  • Actionable genomic alterations must have been treated or offered appropriate targeted therapy
  • Not eligible for additional curative therapy
  • At least one measurable lung lesion per RECIST v1.1 (measurable extra-pulmonary thoracic lesions do not qualify unless a measurable lung lesion is also present)
  • ECOG performance status ≤2
  • Life expectancy ≥12 weeks
  • Adequate hematologic, renal, hepatic, and cardiovascular function
  • Washout from prior therapy ≥30 days or ≥5 half lives
  • Adequate pulmonary reserve: FEV1 ≥50% predicted, FEV1/FVC ≥45%, and DLCO ≥50% predicted
  • No growth factor support, transfusions, or albumin within 14 days prior to first dose
  • Resolution of adverse effects of prior therapy to Grade ≤1 (except fatigue, alopecia, and peripheral neuropathy)
  • Contraception requirements for WOCBP and fertile men
  • Agreement to refrain from smoking or inhaled substances during treatment

Who cannot join

  • Systemic metastases beyond the lung, thoracic lymph nodes, or mediastinum region
  • Anticancer therapy within 30 days or 5 half-lives, or current immunomodulator requirement
  • Hypersensitivity to study drug or device components
  • Concurrent anticancer therapy or immunomodulators
  • Systemic or inhaled corticosteroids (exceptions apply)
  • Active smokers within past 6 months
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  • Severe airway disease (criteria defined)
  • Radiation therapy within 6 months
  • Contraindication to study procedures
  • Other malignancies except specified low risk types
  • Major surgery within 4 weeks
  • Clinically significant cardiovascular disease
  • Uncontrolled medical conditions
  • Active infection requiring IV therapy
  • Live vaccine within 2 weeks of Cycle 1 Day 1
  • Bleeding disorder unrelated to cancer
  • Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

    Carrie Smith, RN

    Nashat Gabrail, MD

Other trials in United States

About this study

Official title: A Phase 1/2 Open-label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NHT102 (5-Azacytidine Dry Powder Formulation Delivered by a Novel Inhalation Delivery System) in Patients With Advanced Non-Small Cell Lung Cancer

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:

Read more

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.
Read the detailed description

This is an open label, multi-center Phase 1/2 study of NHT102, 5-Azacytidine Mircronised, Dry Powder Formulation Delivered by a Novel Inhalation Delivery System (device constituent product [DCP]). The study will enroll patients with advanced NSCLC limited to the lung and thoracic region. The study consists of three sequential parts:

Part 1 (Dose Escalation): Approximately five dose levels of NHT102 will be evaluated using a standard 3+3 design to determine dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD). Patients receive NHT102 once daily on Days 1-5 and Days 15-19 of each 28 day cycle. A Safety Review Committee (SRC) will review safety data after each cohort completes the DLT evaluation period.

Part 2 (Dose Optimization): At least two dose levels selected from Part 1 will be evaluated using Simon's two stage design. Each dose level will enroll up to 25 evaluable patients to assess anti-tumor activity, safety, pharmacokinetics (PK), pharmacodynamics, and exploratory biomarkers.

Part 3 (Dose Expansion): The recommended Phase 2 dose (RP2D) selected from Part 2 will be further evaluated to characterize safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity.

Patients will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, investigator decision, or study termination. Follow up includes safety assessment at 30 days after end of treatment and 6 month survival follow up.

Being tested
NHT102, DryNeb
Keywords
Lung Cancer, Non-small cell
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • NHT102Drug

    Also called 5-AZA, 5-Azacytidine dry powder, NHT102-5-AZA, Azacitidine

    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.

  • DryNebDevice

    Also called Clinical Benchtop DryNeb, Novel Inhalation Delivery System

    The DryNeb is a novel investigational inhalation delivery system that delivers micronized dry powder to the lungs.

Study groups in NCT07864584
Study groupRoleWhat they receive
Dose EscalationExperimentalParticipants 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
Receives: Drug: NHT102; Device: DryNeb
Dose OptimizationExperimentalParticipants 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.
Receives: Drug: NHT102; Device: DryNeb
Dose ExpansionExperimentalParticipants receive NHT102 at the recommended Phase 2 dose (RP2D) determined from Part 2. This part further evaluates safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity.
Receives: Drug: NHT102; Device: DryNeb

What is being measured

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

  1. Incidence and Severity of Adverse Events (AEs)

    Treatment emergent adverse events, serious adverse events, and clinically significant laboratory or vital sign abnormalities assessed using CTCAE v6.0 (Part I).

    Measured: From first dose through 30 days after the last dose.

  2. Incidence of dose-limiting toxicities (DLT)-Part I

    Number of participants experiencing DLTs during the DLT evaluation period, defined per protocol.

    Measured: 28-day DLT evaluation period (Cycle 1)

  3. Overall Response Rate (ORR)-Parts 2 and 3.

    Proportion of participants achieving complete or partial response per RECIST v1.1.

    Measured: From first dose until first documented disease progression, date of death or patient withdrawal from the study for any reason, assessed up to six months.

  4. Progression Free Survival (PFS)-Parts 2 and 3.

    Time from first dose to disease progression or death.

    Measured: From first dose until first documented disease progression, date of death or patient withdrawal from the study for any reason, assessed up to six months.

  5. Overall Survival (OS)-Parts 2 and 3.

    Time from first dose to death.

    Measured: From first dose until first documented disease progression, date of death or patient withdrawal from the study for any reason, assessed up to six months.

  6. Duration of Response (DOR)-Parts 2 and 3.

    Time from first observation of response to progression or death.

    Measured: From first documented response to date of first documented disease progression, date of death or patient withdrawal from the study for any reason, assessed up to six months.

Secondary outcomes (6)

  1. Pharmacokinetic Parameters of NHT102-Parts 1, 2, and 3.

    To determine the PK parameter for the peak plasma concentration (Cmax).

    Measured: At the end of Cycle 1. (Each cycle is 28 days)

  2. Incidence and Severity of Adverse Events (AEs)-Parts 2 and 3.

    TEAEs, SAEs, and clinically significant abnormalities assessed using CTCAE v6.0.

    Measured: From first dose through 30 days after the last dose.

  3. Percent Change in DNA Methylation-Parts 2 and 3.

    Percent change in global DNA methylation in tumor and/or bronchial epithelium compared with pre treatment.

    Measured: Baseline to post-treatment (estimated to be minimum of 7 months)

  4. PK parameters of NHT102. Parts 1, 2, and 3.

    Area under the curve (AUC) plasma concentration versus time curve.

    Measured: At the end of Cycle 1. (Each cycle is 28 days)

  5. PK Parameters of NHT102. Parts 1, 2, and 3.

    Time to maximum plasma concentration (Tmax)

    Measured: At the end of cycle 1. (Each cycle is 28 days)

  6. PK parameters of NHT102. Parts 1, 2 and 3.

    Estimated time to reduce the plasma concentration by exactly one half (T1/2)

    Measured: At the end of Cycle 1. (Each Cycle is 28 days)

Timeline

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

  1. First posted8 Oct 2026
  2. Study start11 Jan 2027 (estimated)
  3. Primary completion13 Jul 2029 (estimated)
  4. Study completion12 Jul 2030 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part I-Dose Escalation Part 2-Dose Optimization. Part 3-Dose Expansion.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07864584
Sponsor's protocol ID
NHT102-001
Status last verified
Oct 2026
First submitted
10 Sep 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No: At the current time, there are no plans to show de-identified individual patient data but only aggregate data.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NHT102 and DryNeb in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Nob Hill Therapeutics, Inc. at 1 site 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 19 inclusion and 17 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: opening soon, as of the sponsor's last update on 8 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 1 site 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Incidence and Severity of Adverse Events (AEs) (time frame: From first dose through 30 days after the last dose.). The study lists 6 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 NCT07864584.

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 8 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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