A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Last updated: March 19, 2026
Sponsor: Nimbus Wadjet, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

NDI-219216

Clinical Study ID

NCT06898450
9216-101
  • Ages 18-99
  • All Genders

Study Summary

The goal of this clinical trial is to learn if NDI-219216 is safe for patients, and if NDI-219216 might be a possible treatment for advanced solid tumors in the later phases of the study.

The main questions it aims to answer are:

Is NDI-219216 safe and what kinds of side effects might it cause? What kind of effects does NDI-219216 have on the body? Does NDI-219216 have any impact on tumor size?

Participants will:

Take NDI-219216 every day by mouth. Visit the clinic 6 times during Cycle 1, 2 times during Cycle 2, once a month thereafter for checkups and tests while on the study, then one time for an end of treatment visit. After the End of Study, a follow up will occur but can be done on the phone.

Keep a diary of their tablet consumption and symptoms experienced.

Eligibility Criteria

Inclusion

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 therapyexists

  • 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, radiationtherapy, or surgical procedures to Grade ≤ 1 (except fatigue, alopecia, andperipheral neuropathy).

Exclusion

Exclusion Criteria:

  • Clinically significant cardiovascular disease.

  • Patients with known WRN syndrome.

  • Pregnancy, breastfeeding, or intention of becoming pregnant during the study.

Study Design

Total Participants: 134
Treatment Group(s): 1
Primary Treatment: NDI-219216
Phase: 1/2
Study Start date:
March 31, 2025
Estimated Completion Date:
December 31, 2031

Study Description

Study 9216-101 is a first-in-human (FIH), Phase 1/2, open-label, dose escalation, dose optimization, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-219216 in patients with advanced solid tumors.

Connect with a study center

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool 2159851, New South Wales 2155400 2170
    Australia

    Site Not Available

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit

    Bedford Park 2076918, South Australia 2061327 5042
    Australia

    Site Not Available

  • BC Cancer Center

    Kelowna, British Columbia V1Y1E2
    Canada

    Site Not Available

  • BC Cancer Center

    Kelowna 5990579, British Columbia 5909050 V1Y1E2
    Canada

    Site Not Available

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G2C4
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Center

    Toronto 6167865, Ontario 6093943 M5G2C4
    Canada

    Site Not Available

  • McGill University Health Centre (MUHC)

    Montreal, Quebec H3A3J1
    Canada

    Site Not Available

  • McGill University Health Centre (MUHC)

    Montreal 6077243, Quebec 6115047 H3A3J1
    Canada

    Site Not Available

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

    Paris, 75012
    France

    Active - Recruiting

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

    Paris 2988507, 75012
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, 86021
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers 2986495, 86021
    France

    Site Not Available

  • START Dublin

    Dublin, D07 R2WY
    Ireland

    Active - Recruiting

  • START Dublin

    Dublin 2964574, D07 R2WY
    Ireland

    Site Not Available

  • START Lisbon

    Lisbon, 1649-028
    Portugal

    Active - Recruiting

  • START Lisbon

    Lisbon 2267057, 1649-028
    Portugal

    Site Not Available

  • CHA University-Bundang Medical Centre

    Seongnam-si, Gyeonggi-do 13496
    South Korea

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 02841
    South Korea

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    South Korea

    Site Not Available

  • Severance Hospital

    Seoul, 03722
    South Korea

    Site Not Available

  • START Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • START Barcelona

    Barcelona 3128760, 08023
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Beatson Clinical Research Facility

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Beatson Clinical Research Facility

    Glasgow 2648579, G12 0YN
    United Kingdom

    Site Not Available

  • Sarah Cannon Research Institute UK

    London, W1G 6AD
    United Kingdom

    Active - Recruiting

  • Sarah Cannon Research Institute UK

    London 2643743, W1G 6AD
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust UK

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust UK

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • USC San Diego Health

    La Jolla, California 92093
    United States

    Site Not Available

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles 5368361, California 5332921 90089
    United States

    Site Not Available

  • Life Clinical Trials

    Coral Springs 4151909, Florida 4155751 33065
    United States

    Site Not Available

  • University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Chicago Medicine

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • University of Louisville James Graham Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University of Louisville James Graham Brown Cancer Center

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Cayuga Cancer Center

    Ithaca, New York 14850
    United States

    Terminated

  • Cayuga Cancer Center

    Ithaca 5122432, New York 5128638 14850
    United States

    Site Not Available

  • Levine Cancer Center

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Atrium Health Levine Cancer Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Taylor Cancer Research Center

    Maumee, Ohio 43537
    United States

    Active - Recruiting

  • Taylor Cancer Research Center

    Maumee 5162137, Ohio 5165418 43537
    United States

    Site Not Available

  • Brown University Health

    Providence, Rhode Island 02901
    United States

    Active - Recruiting

  • Brown University Health

    Providence 5224151, Rhode Island 5224323 02901
    United States

    Site Not Available

  • Prisma Health Cancer Institute - Multidisciplinary Center

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute - Multidisciplinary Center

    Greenville 4580543, South Carolina 4597040 29605
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • University of Virginia Emily Couric Clinical Cancer Center

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, P.C. - Fairfax

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • University of Virginia Emily Couric Clinical Cancer Center

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Site Not Available

  • Virginia Cancer Specialists, P.C. - Fairfax

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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