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An open-label phase I study of AS-0141 in patients with advanced, metastatic, relapsed or refractory malignancies

An open-label phase I study of AS-0141 in patients with advanced, metastatic, relapsed or refractory malignancies

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031210072
Enrollment
85
Registered
2021-05-07
Start date
2021-06-11
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Solid tumors and hematologic malignancies (AML, MDS, DLBCL)

Interventions

AS-0141 will be orally administered twice a day (5 days on/2 days off, or everyday) in a 21-day treatment cycle. The starting dose will be 40 mg/day.

Sponsors

Arimura Akinori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Aged >18 years at time of informed consent - Histlogically confirmed solid tumors, AML, MDS, or DLBCL for which no standard therapy is available - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <= 1 (solid tumors and DLBCL) or <= 2 (AML and MDS) - Life expectancy at least 3 months (90days)

Exclusion criteria

Exclusion criteria: - Patient with known high microsatellite instability(MSH-H) - Any of the following complicating desease 1) Uncontrolled diabetes 2) Interstitial pneumonia, pulumonary fibrosis, radiation pneumonia (including history) 3) Active infection disease requiring systemic treatment such as antimicrobial agent, antivirus agent 4) AML patients with leukocytosis over 30,000/mm^3 in peripheral leukocyte count - Any of following serious cardiac or cardiovascular condition 1) Congestive heart failure 2) Class III/ IV heart failure according to the New York Heart Association [NYHA] criteria 3) Ischemic myocardial disease (angina pectoris which needs treatment or revascularization, miocardinal infarction, unstable and symptomatic ischemic heart disease, etc) within 6 months before study drug administration 4) Uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia) 5) Uncontrolled hypertension 6) Ischemic cerebrovascular accident (history of transient ischemic attack, arterial blood circulation reconstruction, etc.)

Design outcomes

Primary

MeasureTime frame
Dose limiting toxicity

Contacts

Public ContactAkinori Arimura

Carna Biosciences, Inc.

clinical@dd.carnabio.com+81-78-302-7040

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026