Recruiting
Phase 1

RPT1G

Sponsor:

Remedy Plan, Inc.

Code:

NCT07107126

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RPT1G

Study Details

Brief summary:

The main goals of this study are to learn if RPT1G is safe and tolerable and to determine the best dose and schedule of RPT1G for patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Study ID

NCT07107126

Start date

Feb 13, 2026

Status verified date

Mar, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Histological confirmation of AML (ELN 2022 criteria) that relapsed and/or refractory AML or high-risk MDS as defined by International Consortium for MDS (icMDS) 2023 criteria that have received appropriate standard of care therapy, in the opinion of the investigator or declined receipt of these
  • Organ function/reserve as per the following laboratory criteria:
  • Hepatic: Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤2.5 x ULN, and total bilirubin <2 x ULN (except for study patients with known Gilbert's where 1.5 x UL of the subject's baseline or in the case of suspected Gilbert's syndrome where a maximum total bilirubin level of 4.0 mg/dL is acceptable) for the local laboratory. If due to disease, higher values may be approved after discussion with medical monitor.
  • Renal: Adequate renal function as defined by calculated creatinine clearance >50 mL/min for the CLIA certified local laboratory. Creatinine clearance must be calculated by Cockcroft-Gault equation.

Key Exclusion Criteria:

  • Patients without evidence of blood or marrow involvement
  • Acute promyelocytic leukemia
  • Symptomatic central nervous system involvement by AML
  • Clinical signs/symptoms of leukostasis requiring urgent therapy
  • Active infections
  • Radiotherapy <14 days prior to the first day of RPT1G administration
  • Ongoing complications from prior therapy
  • Prior or concurrent malignancy
  • Any other condition, therapy, treatment, or comorbidity that leads the investigator to determine that the study is not in the best interest of the patient

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Starting Dose of RPT1G

experimental: Cohort 2

2nd ascending dose of RPT1G

experimental: Cohort 3

3rd ascending dose of RPT1G

experimental: Cohort 4

4th ascending dose of RPT1G

Interventions

RPT1G

RPT1G is a selective hyperbolic NAMPT inhibitor. RPT1G is administered orally.

Primary outcome measure

  • Incidence and nature of dose-limiting toxicity(ies) (DLTs) [ Time Frame: 3 years ]
  • Incidence of adverse events, serious adverse events, and treatment-emergent adverse events [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Eunice Vukosavljevic, CP, Director of Clinical Operations

240-408-4854clinical@remedyplan.com

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Remedy Plan, Inc.

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Remedy Plan, Inc. on 2026-03-25.