RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2 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

Quick Facts

Study Start:2025-03-31
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06898450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  2. * 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
  3. * Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation)
  4. * Adequate bone marrow / hematologic, end-organ, and cardiovascular function
  5. * 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).
  1. * Clinically significant cardiovascular disease.
  2. * Patients with known WRN syndrome.
  3. * Pregnancy, breastfeeding, or intention of becoming pregnant during the study.

Contacts and Locations

Study Contact

Sean Rossi
CONTACT
857-600-8779
sean.rossi@nimbustx.com
Katie Ard, MSN
CONTACT
303-646-7297
katie.ard@nimbustx.com

Principal Investigator

Anita Scheuber, MD, PhD
STUDY_DIRECTOR
Nimbus Therapeutics, Inc.

Study Locations (Sites)

USC San Diego Health
La Jolla, California, 92093
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089
United States
University of Chicago Medicine
Chicago, Illinois, 60637
United States
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202
United States
Cayuga Cancer Center
Ithaca, New York, 14850
United States
Taylor Cancer Research Center
Maumee, Ohio, 43537
United States
Brown University Health
Providence, Rhode Island, 02901
United States
Prisma Health Cancer Institute - Multidisciplinary Center
Greenville, South Carolina, 29605
United States
Tennessee Oncology
Nashville, Tennessee, 37205
United States
University of Virginia Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22908
United States
Virginia Cancer Specialists, P.C. - Fairfax
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Nimbus Wadjet, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31
Study Completion Date2031-12

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2031-12

Terms related to this study

Keywords Provided by Researchers

  • Advanced Solid Tumors
  • Microsatellite Instability
  • Deficient Mismatch Repair
  • Werner syndrome helicase

Additional Relevant MeSH Terms

  • Advanced Solid Tumors Cancer
  • MSI-H Cancer