Advanced Solid Tumors Cancer study: NDI-219216
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, taken by mouth monthly, 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 study aims to find out if NDI-219216 is safe, what side effects it may cause, how it behaves in the body, and whether it can shrink tumors.
- Who it's for
- Adults who have advanced solid tumors, including those with microsatellite instability‑high (MSI‑H) cancer.
- What's involved
- Participants will take an NDI-219216 tablet every day, keep a diary of doses and symptoms, and undergo clinic visits for check‑ups and tests as scheduled.
- Time commitment
- The trial includes 6 visits in the first cycle, 2 visits in the second cycle, monthly visits thereafter, an end‑of‑treatment visit, and a final phone follow‑up.
- 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 is enrolling
- Los Angeles, California, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, 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
- London, United Kingdom
+ 1 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, but 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?
This study is enrolling now at Los Angeles, California, United States; Chicago, Illinois, United States; Louisville, Kentucky, United States; Charlotte, North Carolina, United States; Winston-Salem, North Carolina, United States; Maumee, Ohio, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.