NCT02440685

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Asana BioSciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	ASN002 Dose Escalation	Multiple ascending doses of ASN002 assigned by cohort
DRUG	ASN002 RD	Recommended dose of ASN002 from Part A

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-06-01
• Completion: 2018-07-01
• First posted: 2015-05-12
• Last updated: 2023-06-07
• Results posted: 2023-06-07

Locations

14 sites across 2 countries: United States, Argentina

Regulatory

• FDA-regulated drug study