A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors

NCT ID: NCT02440685

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-07-31

Brief Summary

This study is a dose escalation, and cohort expansion study in subjects with advanced cancer for which no standard therapy exists. Subjects must have received prior treatment for cancer that has not worked, or has stopped working.

Detailed Description

The study will be conducted in two parts. Part A is a dose escalation study to determine a safe and tolerable dose of ASN002 for subjects with relapsed or refractory lymphoma, or advanced solid tumors. Part A will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling. Subjects in Part B will enroll subjects with four types of lymphoma Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL) and Peripheral T-cell lymphoma (PTCL). Additional groups of subjects with Myelofibrosis (MF) and Chronic Lymphocytic Leukemia (CLL) will be enrolled. Subjects will be treated with the highest safe and tolerable dose determined in Part A of the study to determine preliminary efficacy. Subjects may continue to receive ASN002 for up to 1 year in the absence of severe side effects or disease progression.

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Cancer; Neoplasm; Tumor; Lymphoma, Malignant; Lymphoma, B-cell; Lymphoma, Non-Hodgkin; B-Cell Chronic Lymphocytic Leukemia; B-Cell Leukemia, Chronic; B-Lymphocytic Leukemia, Chronic; Chronic Lymphocytic Leukemia; Leukemia, Lymphocytic, Chronic; Leukemia, Lymphocytic, Chronic, B Cell; Myelofibrosis; Chronic Idiopathic Myelofibrosis; Idiopathic Myelofibrosis; Lymphoma, T Cell, Peripheral; Peripheral T-Cell Lymphoma; T-Cell Lymphoma, Peripheral

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A ASN002 Dose Escalation

Multiple ascending doses of ASN002 will be administered to determine the maximum tolerated dose (MTD). Arm Closed

Group Type: EXPERIMENTAL

ASN002 Dose Escalation

Intervention Type: DRUG

Multiple ascending doses of ASN002 assigned by cohort

Part B ASN002 Recommended dose (RD)

ASN002 administered at the recommended dose

Group Type: EXPERIMENTAL

ASN002 RD

Intervention Type: DRUG

Recommended dose of ASN002 from Part A

Interventions

ASN002 Dose Escalation

Multiple ascending doses of ASN002 assigned by cohort

Intervention Type: DRUG

ASN002 RD

Recommended dose of ASN002 from Part A

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent obtained prior to any study-related procedure being performed;
• Male or female subjects at least 18 years of age at the time of consent;
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
• Recovered from the reversible effects of prior antineoplastic therapy (with the exception of alopecia and Grade 1 neuropathy).
• Screening blood counts of the following: Absolute neutrophil count ≥ 1000/μL, Platelets ≥ 75,000/μL, Hemoglobin ≥ 8 g/dL (with transfusion support);
• Screening chemistry values of the following: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3.0 × upper limit of the normal (ULN), total bilirubin ≤ 1.5 × ULN, Creatinine ≤ 1.5 × ULN;
• At screening, life expectancy of at least 3 months;
• Subject is willing and able to comply with all protocol required visits and assessments;
• Male and female subjects of child-bearing potential must agree to use medically acceptable methods of birth control throughout the study and for thirty (30) days after the last dose of study medication.
• (Part A only) Histologically or cytologically confirmed metastatic and/or advanced solid tumors or lymphomas for which no standard therapy exists, or who are not eligible for standard treatment. Subjects must have received at least one prior therapy for their malignancy;
• (Part B only) Histologically confirmed DLBCL/MCL/FL/PTCL/MF/CLL on the basis of excisional lymph node or extranodal tissue biopsy; diagnosis of relapsed/refractory disease defined as 1) recurrence of disease after a Complete Response (CR), or 2) Partial Response (PR), Stable Disease (SD) at completion of treatment regimen preceding entry into study, subjects must not be candidates for standard therapy, subjects who have not received Stem Cell Translplant (SCT) must be ineligible to receive SCT.

Exclusion Criteria

• Have received prior chemotherapy regimens within 4 weeks of Day 1;
• Have received prior treatment with monoclonal antibodies within 6 weeks of first dose of Day 1;
• Have had major surgery within 30 days prior to the start of Day 1;
• Received any investigational treatment within 4 weeks prior to the start of study medication;
• Have had an infection requiring the use of parenteral antibiotics within 14 days prior to the start of Day 1;
• Have known central nervous system metastasis or Central Nervous System lymphoma;
• Is receiving high dose corticosteroids (>10 mg prednisone daily or equivalent);
• Has known bleeding diathesis that would be a safety risk;
• Has a history of other malignancy within the 3 years prior to screening, except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ;
• Has difficulty swallowing medications, or known history of malabsorption syndrome;
• Has a serious concurrent medical condition, such as: congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening, 12-Lead electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant including myocardial infarction, angioplasty, or cardiac stent placement within the last 6 months, HIV infection, known Hepatitis B or C infection. Subjects at high risk for Hepatitis B or C infection should have serology testing to rule out infection, a medical condition requiring the therapeutic use of anticoagulants.
• Known hypersensitivity to ASN002 or its excipients;
• Prior participation, i.e., receipt of study medication, in this study;
• Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures;
• Female subjects that are pregnant or lactating.
• Part B only: Prior treatment with SYK or Janus Kinase (JAK) inhibitors, except MF subjects.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asana BioSciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niranjan Rao, PhD

Role: STUDY_DIRECTOR

Asana BioSciences

Locations

Arizona Oncology

Tempe, Arizona, United States

University of California, San Francisco

San Francisco, California, United States

Winship Cancer Institute - Emory

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

START - Midwest

Grand Rapids, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Gabrail Cancer Center

Canton, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Hospital Universitario Austral

Buenos Aires, Derqui, Pilar, Argentina

Instituto Alexander Fleming

Buenos Aires, , Argentina

Countries

United States; Argentina

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ASN002-101

Identifier Type: -

Identifier Source: org_study_id