A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Part of paid clinical trials in Los Angeles, California.

Sponsor
Nimbus Wadjet, Inc.
Study ID
NCT06898450
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors Cancer
  • MSI-H Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
May 2026
Primary completion
Oct 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
134 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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). ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90089
Josef Lenz, MD; FACP (PRINCIPAL_INVESTIGATOR)
University of Chicago MedicineChicagoIllinois60637
John Moroney, MD (PRINCIPAL_INVESTIGATOR)
University of Louisville James Graham Brown Cancer CenterLouisvilleKentucky40202
Rebecca Redman, MD (PRINCIPAL_INVESTIGATOR)
Cayuga Cancer CenterIthacaNew York14850-
Levine Cancer CenterCharlotteNorth Carolina28204
R. Wendel Naumann, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health Wake Forest Baptist CenterWinston-SalemNorth Carolina27157
R. Wendel Naumann, MD (PRINCIPAL_INVESTIGATOR)
Taylor Cancer Research CenterMaumeeOhio43537
John Nemunaitis, MD (PRINCIPAL_INVESTIGATOR)
Brown University HealthProvidenceRhode Island02901
Benedito Carneiro Filho, MD; MS; PhD (PRINCIPAL_INVESTIGATOR)
Prisma Health Cancer Institute - Multidisciplinary CenterGreenvilleSouth Carolina29605
William Edenfield, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Emily Couric Clinical Cancer CenterCharlottesvilleVirginia22908
Matthew Reilley, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer Specialists, P.C. - FairfaxFairfaxVirginia22031
Alexander Spira, MD;PhD;FACP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of Chicago Medicine· Chicago, ILUniversity of Louisville James Graham Brown Cancer Center· Louisville, KYCayuga Cancer Center· Ithaca, NYLevine Cancer Center· Charlotte, NCAtrium Health Wake Forest Baptist Center· Winston-Salem, NC

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