IRB #

STUDY00015836

Title

A Phase 1/2, Open-Label, Uncontrolled, Multiple-Dose Escalation, Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ASN002 in Relapsed/Refractory Lymphoma, Myelofibrosis, Chronic Lymphocytic Leukemia and Advanced Solid Tumors

Principal Investigator

Andy Chen

Study Purpose

This study has two parts, Part A and Part B. The purpose of Part A is to find the best acceptable dose of the study drug (ASN002), and to see if it has any effects in participants with relapsed/refractory Diffuse Large B- cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantel Cell Lymphoma (MCL) or Advanced Solid Tumors.

The purpose of Part B is to see if the study drug at 75mg twice a day has any effects in participants with relapsed/refractory DLBCL, FL, MCL, Peripheral T-cell Lymphoma (PTCL), Myelofibrosis (MF), and Chronic Lymphocytic Leukemia (CLL).

Medical Condition(s)

Relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Peripheral T-cell Lymphoma (PTCL), Myelofibrosis (MF), and Chronic Lymphocytic Leukemia (CLL).

Eligibility Criteria

- At least 18 years old

- Relapsed/refractory DLBCL, MCL, FL, PTCL, MF, and CLL. Participants must have received at least one regimen of treatment for lymphoma. Participants must not be candidates for standard therapy. Participants who have not received a stem cell transplant must be ineligible to receive a stem cell transplant.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

If you join this study, you may take the study drug as long as you do not have severe side effects and your investigator feels that you are benefitting from the drug. This could be from less than a month to over a year, depending on how you respond to the study drug.

The study will include a screening period (up to 28 days) and a treatment period up to 12 months. Participants who are being helped by the study drug may continue on an extension study past 12 months.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Asana Biosciences, LLC

Recruitment End

01/01/2020

Compensation Provided

No


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