Recruiting PHASE1, PHASE2 Advanced Solid Tumors Cancer

Tests treatment safety and results for Advanced Solid Tumors Cancer

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

ClinicalTrials.gov ID: NCT06898450

What this study is testing

What is NDI-219216?

NDI-219216 is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for advanced solid tumors cancer.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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?
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 99

You may be able to join if

  • 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...
  • 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...

You likely can't join if

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

The study team makes the final eligibility decision.

Where it's taking place

  • Los Angeles, California, United States
  • Chicago, Illinois, United States
  • Louisville, Kentucky, United States
  • Ithaca, New York, United States
  • Charlotte, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Maumee, Ohio, United States
  • Providence, Rhode Island, United States
  • Greenville, South Carolina, United States
  • Charlottesville, Virginia, United States
  • Fairfax, Virginia, United States
  • Liverpool, New South Wales, Australia
  • Bedford Park, South Australia, Australia
  • Toronto, Ontario, Canada
  • Paris, France
  • Poitiers, France
  • Dublin, Ireland
  • Lisbon, Portugal
  • Barcelona, Spain
  • Madrid, Spain

+ 2 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Los Angeles, California, United States; Chicago, Illinois, United States; Louisville, Kentucky, United States; Ithaca, New York, United States; Charlotte, North Carolina, United States; Winston-Salem, North Carolina, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.