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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

Arimura Akinori

Carna Biosciences, Inc.

1-5-5 Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

clinical@dd.carnabio.com

Arimura Akinori

Carna Biosciences, Inc.

1-5-5 Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

+81-78-302-7040

clinical@dd.carnabio.com

Recruiting

May. 17, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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)

- 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.)

Both

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

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.

Dose limiting toxicity

+81-3-3542-2511

Yes

The IPD will be shared at the appropriate time, but details are undecided.

none