A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011240057

Enrollment

Registered

2024-11-28

Start date

2024-12-27

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Interventions

The study will consist of 2 parts: Part 1 Dose Escalation is a standard 3+3 dose escalation design, consisting of approximately 2 planned dose escalation cohorts that have been deemed safe and tolerab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.>=18 years of age at the time of signing the informed consent 2. Japanese 3.BCR:ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs. 4.Prior bone marrow transplant allowed if >=6 months prior to the first dose of ELVN-001 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6.Screening laboratory values must meet the required criteria within 3 days prior to the first dose of ELVN-001

Exclusion criteria

Exclusion criteria: 1.Uncontrolled cardiovascular condition, including ongoing cardiac arrythmias, congestive heart failure, angina, or myocardial infarction within the past 3 months 2.History of another active malignancy within 2 years prior to study entry except for previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively 3.History of acute TKI-related pancreatitis within 6 months of study entry; or active chronic pancreatitis or pancreatic disease due to any cause 4.Acute or chronic liver disease

Design outcomes

Primary

Measure	Time frame
- Incidence of dose-limiting toxicities (DLTs) - Incidence of adverse events (AEs), laboratory abnormalities, and electrocardiogram (ECG) abnormalities	—

Secondary

Measure	Time frame
- PK parameters: area under the plasma concentration-time curve (AUC), maximum concentration (Cmax), time at which Cmax is observed (tmax), minimum concentration (Cmin), terminal half-life (t1/2), and other parameters such as dose proportionality and accumulation ratio if applicable - Molecular response (MR) as measured by quantitative polymerase chain reaction (qPCR) using the International System (IS)	—

Measure

Time frame

- PK parameters: area under the plasma concentration-time curve (AUC), maximum concentration (Cmax), time at which Cmax is observed (tmax), minimum concentration (Cmin), terminal half-life (t1/2), and other parameters such as dose proportionality and accumulation ratio if applicable - Molecular response (MR) as measured by quantitative polymerase chain reaction (qPCR) using the International System (IS)

—

Contacts

Public ContactYuzo Tomonaga

CMIC Co., Ltd.

ClinicalTrialInformation@cmic.co.jp+81-3-6779-8000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026