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

PHASE1PHASE2RECRUITING

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 details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  2. 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
  3. Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation)
  4. Adequate bone marrow / hematologic, end-organ, and cardiovascular function
  5. 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

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1PHASE2

trial

Study ID

NCT06898450

Intervention or treatment

DRUG: NDI-219216

Conditions

  • Advanced Solid Tumors Cancer
  • MSI-H Cancer

  • Condition: Advanced Solid Tumors Cancer, MSI-H Cancer

  • DRUG: NDI-219216

  • Liverpool, New South Wales, Australia and more

  • Sponsor: Nimbus Wadjet, Inc.

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Liverpool Hospital

Select from list below to view details:

  • Liverpool Hospital

    Liverpool, New South Wales, Australia

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia, Australia

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Who is running the clinical trial?

NWI

Nimbus Wadjet, Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
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.
Drug: NDI-219216
    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.
    Drug: NDI-219216
      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.
      Drug: NDI-219216

        What is the study measuring?

        Primary Outcome

        MeasureDescriptionTime 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 v5.0Assessments 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 InvestigatorAssessments 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.Not SpecifiedFrom 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 v1.1Not SpecifiedFrom 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).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.Not SpecifiedFrom 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.Not SpecifiedFrom 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 Outcome

        MeasureDescriptionTime Frame
        Part A Secondary Objective: Plasma concentrations of NDI-219216 will be measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS) assay.Not SpecifiedAt 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-219216Not SpecifiedAt 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-219216Not SpecifiedAt 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-219216Not SpecifiedAt 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.Not SpecifiedAt 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-219216Not SpecifiedAt 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-219216Not SpecifiedAt 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-219216Not SpecifiedAt 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.Not SpecifiedAt 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-219216Not SpecifiedAt 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-219216Not SpecifiedAt 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-219216Not SpecifiedAt 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.
        Are you running this trial?If you're a clinic or sponsor, you can claim this study.
        Claim this trial

        References

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

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