A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 in Patients With Advanced Solid Tumors With/Without Microsatellite Instability and/or Deficient Mismatch Repair

Study Identifier:
9216-101
CT.gov Identifier:
NCT06898450
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-522774-36-00
Study Contact Information:
N/A
Recruiting

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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.

Part A (Dose Escalation): Bayesian Optimal Interval (BOIN) design to assess safety, maximum tolerated dose (MTD) or maximum administered dose (MTD/MAD), PK and PD of NDI-219216 monotherapy in patients with advanced solid tumors regardless of MSI-H/dMMR status. Dose-limiting toxicities will be assessed during the first cycle and backfilling of MSI-H/dMMR patients will be permitted at cleared doses.

Doses selected in Part A will be further explored for safety and efficacy in MSI-H/dMMR patients during Part B and C of the trial.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Biomarkers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18 - 99 Years
    Study Drug
  • Drug: Experimental: Part A dose escalation
    • Read More
  • Drug: Experimental: Part B Project Optimus
  • Drug: Experimental: Part C Dose Expansion
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.
    • Exclusion criteria include prior exposure to a WRN inhibitor; significant cardiovascular disease; active infections; and uncontrolled CNS metastases.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Biomarkers
    Location
    START Dublin
    Dublin, Ireland, D07 R2WY
    Investigator
    Austin Duffy
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Biomarkers
    Location
    START Lisbon
    Lisbon, Portugal, 1649-035
    Investigator
    Andre Mansinho
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Biomarkers