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

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.

Conditions

Advanced Solid Tumors Cancer, MSI-H Cancer

Study Overview

Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumors Cancer
Intervention / Treatment

-

Contacts and Locations

La Jolla

USC San Diego Health, La Jolla, California, United States, 92093

Los Angeles

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90089

Chicago

University of Chicago Medicine, Chicago, Illinois, United States, 60637

Louisville

University of Louisville James Graham Brown Cancer Center, Louisville, Kentucky, United States, 40202

Ithaca

Cayuga Cancer Center, Ithaca, New York, United States, 14850

Maumee

Taylor Cancer Research Center, Maumee, Ohio, United States, 43537

Providence

Brown University Health, Providence, Rhode Island, United States, 02901

Greenville

Prisma Health Cancer Institute - Multidisciplinary Center, Greenville, South Carolina, United States, 29605

Nashville

Tennessee Oncology, Nashville, Tennessee, United States, 37205

Charlottesville

University of Virginia Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States, 22908

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * Clinically significant cardiovascular disease.
  • * Patients with known WRN syndrome.
  • * Pregnancy, breastfeeding, or intention of becoming pregnant during the study.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nimbus Wadjet, Inc.,

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

Study Record Dates

2031-12