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

NCT ID NCT06898450

Disease control Sponsor: Nimbus Wadjet, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new daily pill called NDI-219216 for people with advanced solid tumors that have not responded to standard treatments. The study will first check safety and side effects, then look at whether the drug can shrink tumors. About 134 participants will take the pill daily and have regular clinic visits for monitoring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NDI-219216 (a WRN inhibitor taken as a daily pill)
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors, especially those with specific genetic features (MSI-H/dMMR).
What could go wrong
This is an early phase 1/2 trial with a small number of participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 134 people

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

Started

Mar 2025

Expected to finish

Dec 2031

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 to 99 years

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: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Have unresectable and/or metastatic solid tumors (with or without MSI-H/dMMR) refractory to or intolerant to previous SoC therapy or for which no SoC therapy exists * Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation) * Adequate bone marrow / hematologic, end-organ, and cardiovascular function * Resolution of all acute (or toxic) adverse effects of prior therapies, radiation therapy, or surgical procedures to Grade ≤ 1 (except fatigue, alopecia, and peripheral neuropathy). Exclusion Criteria: * Clinically significant cardiovascular disease. * Patients with known WRN syndrome. * Pregnancy, breastfeeding, or intention of becoming pregnant during the study.

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Conditions

The condition(s) this trial relates to.

cancer Microsatellite Instability neoplasm Werner syndrome

As listed by the trial registrant

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

Advanced solid tumors cancer Msi-H cancer

How to take part

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

  1. The places running it

    21 sites in 8 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Atrium Health Wake Forest Baptist Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Brown University Health

    RECRUITING

    Providence, Rhode Island, 02901, United States

  • Cayuga Cancer Center

    TERMINATED

    Ithaca, New York, 14850, United States

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    RECRUITING

    Poitiers, 86021, France

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP)

    RECRUITING

    Paris, 75012, France

  • Levine Cancer Center

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G2C4, Canada

  • Prisma Health Cancer Institute - Multidisciplinary Center

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • START Barcelona

    RECRUITING

    Barcelona, 08023, Spain

  • START Dublin

    RECRUITING

    Dublin, D07 R2WY, Ireland

  • START Lisbon

    RECRUITING

    Lisbon, 1649-028, Portugal

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Southern Oncology Clinical Research Unit

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Taylor Cancer Research Center

    RECRUITING

    Maumee, Ohio, 43537, United States

  • The Christie NHS Foundation Trust UK

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90089, United States

  • University of Chicago Medicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Louisville James Graham Brown Cancer Center

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Virginia Emily Couric Clinical Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Virginia Cancer Specialists, P.C. - Fairfax

    RECRUITING

    Fairfax, Virginia, 22031, United States

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