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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NDI-219216 | Drug | NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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). | 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. | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Rossi | Contact | 857-600-8779 | sean.rossi@nimbustx.com | |
| Katie Ard, MSN | Contact | 303-646-7297 | katie.ard@nimbustx.com |
| Name | Affiliation | Role |
|---|---|---|
| Anita Scheuber, MD, PhD | Nimbus Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90089 | United States |
It is not yet known if there will be a plan to make IPD available.
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| 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). | 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. | 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. |
| 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 | 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 | 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. | 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 | 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 | 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 | 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). | 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. | 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 | 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 | 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 | 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. |
| University of Chicago Medicine | Recruiting | Chicago | Illinois | 60637 | United States |
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| University of Louisville James Graham Brown Cancer Center | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Cayuga Cancer Center | Terminated | Ithaca | New York | 14850 | United States |
| Levine Cancer Center | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| Atrium Health Wake Forest Baptist Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Taylor Cancer Research Center | Recruiting | Maumee | Ohio | 43537 | United States |
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| Brown University Health | Recruiting | Providence | Rhode Island | 02901 | United States |
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| Prisma Health Cancer Institute - Multidisciplinary Center | Recruiting | Greenville | South Carolina | 29605 | United States |
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| University of Virginia Emily Couric Clinical Cancer Center | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| Virginia Cancer Specialists, P.C. - Fairfax | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Liverpool Hospital | Recruiting | Liverpool | New South Wales | 2170 | Australia |
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| Southern Oncology Clinical Research Unit | Recruiting | Bedford Park | South Australia | 5042 | Australia |
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| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G2C4 | Canada |
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| Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP) | Recruiting | Paris | 75012 | France |
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| Centre Hospitalier Universitaire (CHU) de Poitiers | Recruiting | Poitiers | 86021 | France |
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| START Dublin | Recruiting | Dublin | D07 R2WY | Ireland |
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| START Lisbon | Recruiting | Lisbon | 1649-028 | Portugal |
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| START Barcelona | Recruiting | Barcelona | 08023 | Spain |
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| Hospital Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
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| Sarah Cannon Research Institute UK | Recruiting | London | W1G 6AD | United Kingdom |
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| The Christie NHS Foundation Trust UK | Recruiting | Manchester | M20 4BX | United Kingdom |
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| ID | Term |
|---|---|
| D053842 | Microsatellite Instability |
| D014898 | Werner Syndrome |
| ID | Term |
|---|---|
| D042822 | Genomic Instability |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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