Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
Nerviano Medical Sciences
Study ID
NCT06549790
Phase
PHASE1
Status
Recruiting
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Conditions

  • Relapsed/Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NMS-03597812 — DRUG
    Route of Administration: Oral

Study Details

The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.

Key Dates

Start date
Oct 16, 2024
Status verified
Oct 2025
Primary completion
Sep 15, 2029
Completion
May 15, 2030

Study Design

Enrollment
124 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NMS-03597812
    Dose escalation (Phase Ia): Administered orally once daily (28 consecutive days) in repeated 4-week cycles. Each cycle is 28 days. Expansion cohorts (Phase Ib, Cohorts A and B): The dose expansion may comprise up to a total of 2 single arms of NMS-03597812 as single agent: * Cohort A: in patients with TP53mt relapsed/refractory acute myeloid leukemia (R/R AML) prior unfit to intensive chemotherapy (IC) who have exhausted standard treatment options * Cohort B: in prior fit or unfit patients to IC with TP53wt R/R AML who have exhausted standard treatment options Backfill cohorts: Optional backfill cohorts may be opened at any time during the conduct of the trial to further evaluate the following items: NMS-03597812 dosing alone, pharmacokinetic (PK), drug-drug interactions, food effects, biomarkers and QTc for NMS-03597812 as single agent.

Primary Outcome Measure

Phase Ia (escalation) - Number of Participants with Adverse Events (AEs) [ Time Frame: Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 13 months) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope - DuarteDuarteCalifornia91010-
Rocky Mountain Cancer CentersAuroraColorado80012-
Medical Oncology Hematology ConsultantsNewarkDelaware19713-
Blood and Marrow Transplant Group of GeorgiaAtlantaGeorgia30342-
Mayo Clinic Cancer Center (MCCC) - RochesterRochesterMinnesota55905-
Gabrail Cancer Research CenterCantonOhio44718-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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City of Hope - Duarte· Duarte, CARocky Mountain Cancer Centers· Aurora, COMedical Oncology Hematology Consultants· Newark, DEBlood and Marrow Transplant Group of Georgia· Atlanta, GAMayo Clinic Cancer Center (MCCC) - Rochester· Rochester, MNGabrail Cancer Research Center· Canton, OH

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