Advanced Solid Tumors CancerPhase 1/2NCT06898450
A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
A Phase 1/2 study testing NDI-219216 in people with Advanced Solid Tumors Cancer and MSI-H Cancer, run by Nimbus Wadjet, Inc. at 22 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Solid Tumors Cancer, MSI-H Cancer
- What is being tested?
- NDI-219216
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 22 sitesin 8 countries
- Study dates
- 31 Mar 2025to Dec 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Clinically significant cardiovascular disease.
- Patients with known WRN syndrome.
- Pregnancy, breastfeeding, or intention of becoming pregnant during the study.
Trial locations and contacts
22 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 8 countries
United States11 sites, 10 recruiting
- Recruiting
Levine Cancer Center
Charlotte, North Carolina, 28204
R. Wendel Naumann, MD
- Recruiting
University of Virginia Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22908
Matthew Reilley, MD
- Recruiting
University of Chicago Medicine
Chicago, Illinois, 60637
John Moroney, MD
- Recruiting
Virginia Cancer Specialists, P.C. - Fairfax
Fairfax, Virginia, 22031
Alexander Spira, MD;PhD;FACP
- Recruiting
Prisma Health Cancer Institute - Multidisciplinary Center
Greenville, South Carolina, 29605
William Edenfield, MD
- Terminated
Cayuga Cancer Center
Ithaca, New York, 14850
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089
Josef Lenz, MD; FACP
- Recruiting
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Rebecca Redman, MD
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
John Nemunaitis, MD
- Recruiting
Brown University Health
Providence, Rhode Island, 02901
Benedito Carneiro Filho, MD; MS; PhD
- Recruiting
Atrium Health Wake Forest Baptist Center
Winston-Salem, North Carolina, 27157
R. Wendel Naumann, MD
Australia2 sites, 2 recruiting
- Recruiting
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
Ganessan Kichenadasse, MD; PHD
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
Aflah Roohullah, MD; PHD
France2 sites, 2 recruiting
- Recruiting
Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, 75012
Thierry Andre, MD
- Recruiting
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, 86021
David Tougeron, MD
Spain2 sites, 2 recruiting
- Recruiting
START Barcelona
Barcelona, 08023
Roberto Martin Huertas, MD
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Jorge Bartolome, MD
United Kingdom2 sites, 2 recruiting
- Recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
Elisa Fontana, MD
- Recruiting
The Christie NHS Foundation Trust UK
Manchester, M20 4BX
Donna Graham, MD
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario, M5G2C4
Eric Chen, MD; PHD
Ireland1 site, 1 recruiting
- Recruiting
START Dublin
Dublin, D07 R2WY
Austin Duffy, MD
Portugal1 site, 1 recruiting
- Recruiting
START Lisbon
Lisbon, 1649-028
Andre Mansinho, MD
About this study
Official title: A Phase 1 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
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:
Read more
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.
Read the detailed description
Study 9216-101 is a first-in-human (FIH), Phase 1/2, open-label, dose escalation, dose optimization, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-219216 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors Cancer, MSI-H Cancer
- Being tested
- NDI-219216
- Keywords
- Advanced Solid Tumors, Microsatellite Instability, Deficient Mismatch Repair, Werner syndrome helicase
- Medical subject headings
- Microsatellite Instability, Werner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDI-219216Drug
NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.
| Study group | Role | What they receive |
|---|---|---|
| Part A dose escalation | Experimental | Part A Dose Escalation will involve enrolling sequential cohorts with increasing doses of NDI-219216 administered daily in repeating 28-day treatment cycles. The Dose Limiting Toxicity review period for each cohort will be 21 days for each patient enrolled, with review by a Safety Review Committee prior to escalation to the next dose level. Receives: Drug: NDI-219216 |
| Part B Project Optimus | Experimental | Part B will enroll up to 3 cohorts of patients randomized between up to 3 dose levels determined from Part A Dose Escalation. NDI-219216 will be administered daily in repeating 28-day treatment cycles. Receives: Drug: NDI-219216 |
| Part C Dose Expansion | Experimental | Part C will enroll 2 groups of patients with dMMR/MSI-h status and other select criteria, utilizing the optimal dose identified from Part B. NDI-219216 will be administered daily in 28-day repeating cycles. Receives: Drug: NDI-219216 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A Primary Objective: Incidence of dose limiting toxicities (DLTs)
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)
Measured: The first 21 days of Cycle 1 (Cycle 1 is 28 days).
Part A Primary Outcome: • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), according to NCI CTCAE v5.0
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.
Measured: From 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.
Part A Primary Outcome: Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events (TRAEs) as assessed by the Investigator
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).
Measured: From 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.
Part B Primary Objective: Overall Response Rate (ORR) per RECIST v1.1.
Measured: 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 v1.1
Measured: 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 18 months. Each Cycle is 28 days.
Part B Primary Outcome: Incidence and severity of AEs according to NCI CTCAE v5.0.
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).
Measured: 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.
Part C Primary Objective: Overall Response Rate (ORR) per RECIST v1.1.
Measured: 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.
Measured: 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.
Secondary outcomes (13)
Part A Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part A Secondary Outcome: Maximum Plasma Concentration Observed (Cmax) of NDI-219216
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part A Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part A Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1 from time zero to the last observable concentration. Cycle 1 is 28 days in length.
Part B Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part B Secondary Outcome: Maximum Plasma Concentration Observed (Cmax) of NDI-219216
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part B Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part B Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1 from time zero to the last observable concentration. Cycle 1 is 28 days in length.
Part C Secondary Objective: Incidence and severity of AEs according to NCI CTCAE v5.0.
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).
Measured: From first dose of study drug until 30 days after last dose of study drug; up to approximately 17 months. Each Cycle is 28 days.
Part C Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part C Secondary Objective: Maximum Plasma Concentration Observed (Cmax) of NDI-219216
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part C Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part C Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216
Measured: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start31 Mar 2025
- Primary completionOct 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nimbus Wadjet, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Anita Scheuber, MD, PhD, Study director, Nimbus Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898450
- Sponsor's protocol ID
- 9216-101
- Status last verified
- May 2026
- First submitted
- 10 Mar 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 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
- ClinicalTrials.gov ID
- NCT06898450
- Acronym / sponsor ID
- 9216-101
- Conditions
- Advanced Solid Tumors Cancer, MSI-H Cancer
- Keywords
- Advanced Solid Tumors, Microsatellite Instability, Deficient Mismatch Repair, Werner syndrome helicase
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Nimbus Wadjet, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study 9216-101 is a first-in-human (FIH), Phase 1/2, open-label, dose escalation, dose optimization, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-219216 in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A dose escalation | Experimental | Drug: NDI-219216Part A Dose Escalation will involve enrolling sequential cohorts with increasing doses of NDI-219216 administered daily in repeating 28-day treatment cycles. The Dose Limiting Toxicity review period for each cohort will be 21 days for each patient enrolled, with review by a Safety Review Committee prior to escalation to the next dose level. |
| Part B Project Optimus | Experimental | Drug: NDI-219216Part B will enroll up to 3 cohorts of patients randomized between up to 3 dose levels determined from Part A Dose Escalation. NDI-219216 will be administered daily in repeating 28-day treatment cycles. |
| Part C Dose Expansion | Experimental | Drug: NDI-219216Part C will enroll 2 groups of patients with dMMR/MSI-h status and other select criteria, utilizing the optimal dose identified from Part B. NDI-219216 will be administered daily in 28-day repeating cycles. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- Clinically significant cardiovascular disease.
- Patients with known WRN syndrome.
- Pregnancy, breastfeeding, or intention of becoming pregnant during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDI-219216NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity. | Drug | Part A dose escalation, Part B Project Optimus, Part C Dose Expansion |
Primary outcome
Part A Primary Objective: Incidence of dose limiting toxicities (DLTs)
Time frame: 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 v5.0
Time frame: From 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 Investigator
Time frame: From 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.
Time frame: 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 v1.1
Time frame: 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 18 months. Each Cycle is 28 days.
Part B Primary Outcome: Incidence and severity of AEs according to NCI CTCAE v5.0.
Time frame: 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.
Time frame: 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.
Time frame: 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.
13 secondary outcomes
Part A Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part A Secondary Outcome: Maximum Plasma Concentration Observed (Cmax) of NDI-219216
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part A Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part A Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1 from time zero to the last observable concentration. Cycle 1 is 28 days in length.
Part B Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part B Secondary Outcome: Maximum Plasma Concentration Observed (Cmax) of NDI-219216
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part B Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part B Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1 from time zero to the last observable concentration. Cycle 1 is 28 days in length.
Part C Secondary Objective: Incidence and severity of AEs according to NCI CTCAE v5.0.
Time frame: From first dose of study drug until 30 days after last dose of study drug; up to approximately 17 months. Each Cycle is 28 days.
Part C Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part C Secondary Objective: Maximum Plasma Concentration Observed (Cmax) of NDI-219216
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part C Secondary Outcome: Time of Maximum Plasma Concentration Observed (Tmax) of NDI-219216
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Part C Secondary Outcome: Area Under the Plasma Concentration-Time Curve (AUC0-last) of NDI-219216
Time frame: At pre-specified timepoints on Day 1, Day 2, Day 8, Day 21, and Day 22 of Cycle 1. Cycle 1 is 28 days in length.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anita Scheuber, MD, PhD study director
Nimbus Therapeutics, Inc.
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NDI-219216 in people with Advanced Solid Tumors Cancer and MSI-H Cancer, run by Nimbus Wadjet, Inc. at 22 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Australia, France, Spain, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean Rossi (857-600-8779, sean.rossi@nimbustx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A Primary Objective: Incidence of dose limiting toxicities (DLTs) (time frame: The first 21 days of Cycle 1 (Cycle 1 is 28 days).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.