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New pill targets Hard-to-Treat cancers in early trial

NCT ID NCT06326411

Disease control Sponsor: Nested Therapeutics, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests an experimental oral drug called NST-628 in adults with advanced solid tumors that have specific genetic changes in the MAPK pathway. The main goals are to check the drug's safety, find the right dose, and see if it can shrink tumors. About 230 participants who have run out of standard treatment options will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: 1. Subjects must be ≥18 years old (or of legal age of consent in the country in which the study is taking place) at the time of signing the informed consent. 2. Subjects who have a histologically or cytologically documented metastatic or locally advanced solid tumor, for which standard of care (SoC) therapy does not exist, no longer provides benefit, or is not tolerated by the subject, or the subject has been assessed by the Investigator as not being suitable for SoC therapy. 1. Part A: Subjects with any solid tumor with genetic alteration of or evidence of tumor dependence upon the RAS/MAPK pathway (subject to additional restrictions specified in the study protocol) 2. Part B: Subjects must be diagnosed with one of the following solid tumors harboring specified genetic alterations based on a validated local test: i. Melanoma Cohorts: 1. Activating NRAS mutations 2. Select BRAF alterations ii. Non-Melanoma Cohorts: 1. Solid tumors with NRAS activating mutations 2. Solid tumors with KRAS activating mutations 3. Solid tumors with select BRAF alterations 4. Glioma with BRAF alterations 3. Newly obtained or archived tumor tissue is required 4. Part B: measurable disease as defined by RECIST Version 1.1 or by other disease assessment tool standard for a given tumor type (if RECIST v. 1.1 is not standard) 5. Performance status 1. Solid tumors other than glioma: ECOG 0 or 1 2. Glioma: Karnofsky ≥ 70 and ECOG 0 or 1 6. Have adequate organ function 7. Understand and voluntarily sign an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation. 8. Life expectancy ≥ 12 weeks Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: 1. Conditions interfering with oral intake of NST-628 2. Conditions interfering with intestinal absorption of an orally administered drug 3. A history or current evidence of significant retinal pathology leading to increased risk of RVO 4. A history or evidence of cardiovascular risk 5. Current or history within 6 months of planned Cycle 1 Day 1 of pneumonitis or interstitial lung disease (ILD) 6. Part B: prior treatment with any MEK or BRAF inhibitor 7. Untreated or symptomatic central nervous system (CNS) metastases 8. Chemotherapy, radiation, gene therapy, vaccine therapy, or anti-cancer antibodies / ADCs within 28 days of Cycle 1 Day 1 9. Targeted small molecule agents within 14 days or 5 half-lives of Cycle 1 Day 1 10. Females who are pregnant or breastfeeding. 11. For fertile patients (female able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial and for 6 months after the last dose of NST-628 12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study

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Conditions

The condition(s) this trial relates to.

glioma melanoma neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GLIOMA Mapk pathway gene mutation MEK mutation Melanoma NSCLC Oncology Raf gene mutation Ras (KRAS or NRAS) gene mutation Solid tumor, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Cabrini Health Limited

    RECRUITING

    Malvern, Victoria, 3144, Australia

    Contact Email: •••••@•••••

  • Cabrini Hospital

    RECRUITING

    Malvern, Victoria, 3144, Australia

    Contact Email: •••••@•••••

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Gallipoli Medical Research Centre- Greenslopes Private Hospital

    RECRUITING

    Greenslopes, Queensland, 120, Australia

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Slone Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NEXT Oncology - Austin

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Oncology - Dallas

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75039, United States

  • NEXT Oncology - Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Roswell Park

    RECRUITING

    Buffalo, New York, 14263, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START Moutain Region

    COMPLETED

    West Valley City, Utah, 84119, United States

  • Sarah Cannon Research Institute at Health ONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • Scientia Clinical Research, Ltd

    COMPLETED

    Randwick, New South Wales, 2031, Australia

  • Southern Oncology Research Unit

    RECRUITING

    Adelaide, South Australia, 5042, Australia

  • The Kinghorn Cancer Center, St. Vincent's Health Network

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • UCLA Hematology/Oncology

    RECRUITING

    Westwood, Los Angeles, California, 90024, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

    Contact Email: •••••@•••••

  • Vanderbilt-Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Yale Cancer Center

    COMPLETED

    New Haven, Connecticut, 06511, United States

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