Recruiting
Phase 1
Phase 2

NDI-219216

Sponsor:

Nimbus Wadjet, Inc.

Code:

NCT06898450

Conditions

Advanced Solid Tumors Cancer

MSI-H Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NDI-219216

Study Details

Brief 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.

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.

Conditions

Advanced Solid Tumors Cancer

MSI-H Cancer

Study ID

NCT06898450

Start date

Mar 31, 2025

Status verified date

May, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Oct, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Study Design

Enrollment

134 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A dose escalation

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.

experimental: Part B Project Optimus

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.

experimental: Part C Dose Expansion

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.

Interventions

NDI-219216

NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.

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). ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Sean Rossi

857-600-8779sean.rossi@nimbustx.com

Katie Ard, MSN

303-646-7297katie.ard@nimbustx.com

Locations

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90089

Principal Investigator:

Josef Lenz, MD; FACP

University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

John Moroney, MD

University of Louisville James Graham Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator:

Rebecca Redman, MD

Levine Cancer Center

Recruiting

Charlotte, North Carolina, United States, 28204

Principal Investigator:

R. Wendel Naumann, MD

Atrium Health Wake Forest Baptist Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator:

R. Wendel Naumann, MD

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Principal Investigator:

John Nemunaitis, MD

Brown University Health

Recruiting

Providence, Rhode Island, United States, 02901

Principal Investigator:

Benedito Carneiro Filho, MD; MS; PhD

Prisma Health Cancer Institute - Multidisciplinary Center

Recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator:

William Edenfield, MD

University of Virginia Emily Couric Clinical Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

Matthew Reilley, MD

Virginia Cancer Specialists, P.C. - Fairfax

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Alexander Spira, MD;PhD;FACP

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G2C4

Principal Investigator:

Eric Chen, MD; PHD

More Information

Sponsor

Nimbus Wadjet, Inc.

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Advanced Solid Tumors
  • Microsatellite Instability
  • Deficient Mismatch Repair
  • Werner syndrome helicase

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nimbus Wadjet, Inc. on 2026-05-06.