MedTrace Logo

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

NCT06898450 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-05-06

No results posted yet for this 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.

Conditions

  • Advanced Solid Tumors Cancer
  • MSI-H Cancer

Interventions

DRUG

NDI-219216

NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Nimbus Wadjet, Inc.

    lead INDUSTRY

Principal Investigators

  • Anita Scheuber, MD, PhD · Nimbus Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2031-10-31
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Ireland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06898450 on ClinicalTrials.gov