A Study of NDI-219216 for Advanced Solid Tumors
This study is testing a drug called NDI-219216 for people with advanced solid tumors, including those with MSI-H cancer (a type of cancer with specific genetic changes). NDI-219216 works by blocking WRN helicase activity, which may help fight cancer. The main goals are to see if NDI-219216 is safe, what side effects it might cause, and if it can affect tumor size. You might be able to join if you are 18 to 99 years old, have advanced solid tumors that haven't responded to standard treatments or for which no standard treatment exists, and have measurable disease. The study aims to enroll 134 participants. The current recruitment status is unclear.
- Study design
- This is a Phase 1/2, open-label study, meaning both you and your doctors will know you are receiving NDI-219216. It is designed to evaluate the drug's safety, how it moves through the body, and its potential anti-tumor effects in up to 134 participants.
- What's involved
- You will take NDI-219216 by mouth every day. You will have frequent clinic visits, especially early in the study, and will keep a diary of your tablet use and symptoms. Visits will occur 6 times in the first 28-day cycle, 2 times in the second cycle, and then monthly for checkups.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for safety for 30 days after your last dose of NDI-219216, up to approximately 11-12 months. After the study treatment ends, there will be a follow-up visit, which can be done over the phone.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
At a glance
Conditions
NCT06898450
Where you'd take part
This study runs at 22 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Atrium Health Wake Forest Baptist Center
Winston-Salem, North Carolinano site contact published
Recruiting
Brown University Health
Providence, Rhode Islandno site contact published
Recruiting
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Franceno site contact published
Recruiting
Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, Franceno site contact published
Recruiting
Hospital Clinico San Carlos
Madrid, Spainno site contact published
Recruiting
Levine Cancer Center
Charlotte, North Carolinano site contact published
Recruiting
Liverpool Hospital
Liverpool, New South Wales, Australiano site contact published
Recruiting
Princess Margaret Cancer Center
Toronto, Ontario, Canadano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Anita Scheuber, MD, PhD · STUDY_DIRECTOR · Nimbus Therapeutics, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Part A Primary Objective: Incidence of dose limiting toxicities (DLTs)The first 21 days of Cycle 1 (Cycle 1 is 28 days).
Assessments will include electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation)
- Part A Primary Outcome: • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), according to NCI CTCAE v5.0From first dose of study drug until 30 days after last dose of study drug; up to approximately 11-12 months. Each Cycle is 28 days.
Assessments will include standard electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation.
- Part A Primary Outcome: Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events (TRAEs) as assessed by the InvestigatorFrom first dose of study drug until 30 days after last dose of study drug; up to approximately 11-12 months. Each Cycle is 28 days.
Assessments will include standard electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation).
- Part B Primary Objective: Overall Response Rate (ORR) per RECIST v1.1.From start of study treatment until end of follow-up, up to approximately 18 months. Each Cycle is 28 days.
- Part B Primary Outcome: Duration of Response (DOR) per RECIST v1.1From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first; up to approximately 18 months. Each Cycle is 28 days.
- Part B Primary Outcome: Incidence and severity of AEs according to NCI CTCAE v5.0.From first dose of study drug until 30 days after last dose of study drug; up to approximately 18 months. Each Cycle is 28 days.
Assessments will include standard electrocardiograms (ECGs), echocardiogram, cardiac biomarker troponin I, physical examination, vital signs (including blood pressure, pulse), and evaluation of laboratory parameters (clinical chemistry, hematology, and coagulation).
- Part C Primary Objective: Overall Response Rate (ORR) per RECIST v1.1.From start of study treatment until end of follow-up, up to approximately 17 months. Each Cycle is 28 days.
- Part C Primary Outcome: Duration of Response (DOR) per RECIST v1.1.From the time of first occurrence of a documented response until the time of documented disease progression or death from any cause, whichever occurs first, up to approximately 17 months. Each Cycle is 28 days.