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

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

Tomonaga Yuzo

CMIC Co., Ltd.

1-1-1, Shibaura, Minato-ku, Tokyo

ClinicalTrialInformation@cmic.co.jp

Tomonaga Yuzo

CMIC Co., Ltd.

1-1-1, Shibaura, Minato-ku, Tokyo

+81-3-6779-8000

ClinicalTrialInformation@cmic.co.jp

Recruiting

Dec. 11, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Chronic Myeloid Leukemia

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 tolerable in the global study ELVN-001-101, with the starting dose of 80 mg administered orally once daily.
Part 2: Dose Exploration consists of up to approximately 6 participants per dose level who may be enrolled at or below the dose levels that have been deemed safe and tolerable in the Part 1 Dose Escalation portion of the study in order to further evaluate PK and safety at a specific dose level.

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

- 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)

+81-11-563-2211

Nov. 28, 2024

No

none