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

Last updated: May 4, 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

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G2C4
    Canada

    Active - Recruiting

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

    Paris, 75012
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, 86021
    France

    Active - Recruiting

  • START Dublin

    Dublin, D07 R2WY
    Ireland

    Active - Recruiting

  • START Lisbon

    Lisbon, 1649-028
    Portugal

    Active - Recruiting

  • 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

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Sarah Cannon Research Institute UK

    London, W1G 6AD
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust UK

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Active - Recruiting

  • University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Louisville James Graham Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Cayuga Cancer Center

    Ithaca, New York 14850
    United States

    Terminated

  • 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

  • Taylor Cancer Research Center

    Maumee, Ohio 43537
    United States

    Active - Recruiting

  • Brown University Health

    Providence, Rhode Island 02901
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute - Multidisciplinary Center

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • 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

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