A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT02440685 |
Recruitment Status :
Terminated
(Business decision)
First Posted : May 12, 2015
Last Update Posted : August 14, 2018
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Condition or disease | Intervention/treatment | Phase |
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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 | Drug: ASN002 Dose Escalation Drug: ASN002 RD | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | May 2015 |
Actual Primary Completion Date : | June 2018 |
Actual Study Completion Date : | July 2018 |

Arm | Intervention/treatment |
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Experimental: ASN002 Dose Escalation
Multiple ascending doses of ASN002 will be administered to determine the maximum tolerated dose (MTD). Arm Closed
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Drug: ASN002 Dose Escalation
Multiple ascending doses of ASN002 assigned by cohort |
Experimental: ASN002 Recommended dose (RD) - DLBCL
ASN002 administered at the recommended dose in subjects with DLBCL. Arm Closed
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Drug: ASN002 RD
Recommended dose of ASN002 from Part A |
Experimental: ASN002 RD - Mantle Cell Lymphoma
ASN002 administered at the recommended dose in subjects with MCL. Arm Closed
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Drug: ASN002 RD
Recommended dose of ASN002 from Part A |
Experimental: ASN002 RD - Follicular Lymphoma
ASN002 administered at the recommended dose in subjects with FL.
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Drug: ASN002 RD
Recommended dose of ASN002 from Part A |
Experimental: ASN002 RD - Peripheral T-cell Lymphoma
ASN002 administered at the recommended dose in subjects with PTCL.
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Drug: ASN002 RD
Recommended dose of ASN002 from Part A |
Experimental: ASN002 RD - Myelofibrosis
ASN002 administered at the recommended dose in subjects with MF.
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Drug: ASN002 RD
Recommended dose of ASN002 from Part A |
Experimental: ASN002 RD - Chronic Lymphocytic Leukemia
ASN002 administered at the recommended dose in subjects with CLL.
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Drug: ASN002 RD
Recommended dose of ASN002 from Part A |
- Part A: Determine the maximum tolerated dose (MTD) of ASN002 [ Time Frame: First 28 days ]The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity. This is the primary endpoint of Part A
- Part B: evaluate the overall response rate (number of Complete Responses + Partial Responses) in subjects receiving ASN002 for the treatment of lymphoma, MF and CLL. [ Time Frame: First 6 months ]Change from baseline in the severity of disease, This is the primary endpoint for Part B.
- Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN002 [ Time Frame: First 29 days ]Calculate the amount of ASN002 in the bloodstream
- Calculate the maximum plasma concentration (Cmax) at steady state. [ Time Frame: First 29 days ]Calculate the maximum amount of ASN002 in the bloodstream
- Calculate the terminal elimination rate (T 1/2). [ Time Frame: First 29 days ]Calculate how fast ASN002 leaves the body
- To evaluate the change from baseline in the intensity of Phospho-STAT3 protein found in the blood of patients with lymphoma. [ Time Frame: First 29 days ]Evaluate the effect of ASN002 on tumor biomarkers
- To evaluate the change from baseline in the intensity of Phospho-S6 protein found in the blood of patients with lymphoma. [ Time Frame: First 29 days ]Evaluate the effect of ASN002 on biomarkers
- To evaluate the change from baseline in the intensity of Phospho-spleen tyrosine kinase (SYK) 525/526 protein found in the blood of patients with lymphoma.. [ Time Frame: First 29 days ]Evaluate the effect of ASN002 on biomarkers
- To evaluate the change from baseline in the intensity of Phospho-extracellular signal-regulated kinases (ERK) protein found in the blood of patients with lymphoma. [ Time Frame: First 29 days ]Evaluate the effect of ASN002 on biomarkers
- The number of patients who show a decrease from baseline in a serum panel of biomarkers of inflammation [ Time Frame: First 29 days ]Evaluate the effect of ASN002 on biomarkers

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440685
United States, Arizona | |
Arizona Oncology | |
Tempe, Arizona, United States, 85206 | |
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94122 | |
United States, Georgia | |
Winship Cancer Institute - Emory | |
Atlanta, Georgia, United States, 30322 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
START - Midwest | |
Grand Rapids, Michigan, United States, 49503 | |
United States, Mississippi | |
University of Mississippi Medical Center | |
Jackson, Mississippi, United States, 39216 | |
United States, Ohio | |
Gabrail Cancer Center | |
Canton, Ohio, United States, 44718 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
South Texas Accelerated Research Therapeutics | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
Virginia Cancer Specialists | |
Fairfax, Virginia, United States, 22031 | |
Argentina | |
Hospital Universitario Austral | |
Buenos Aires, Derqui, Pilar, Argentina, 1629 | |
Instituto Alexander Fleming | |
Ciudad Autonoma de Buenos Aires, Argentina, 1426 |
Study Director: | Niranjan Rao, PhD | Asana BioSciences |
Responsible Party: | Asana BioSciences |
ClinicalTrials.gov Identifier: | NCT02440685 |
Other Study ID Numbers: |
ASN002-101 |
First Posted: | May 12, 2015 Key Record Dates |
Last Update Posted: | August 14, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
DLBCL FL MCL |
PTCL MF CLL |
Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Lymphoma, Mantle-Cell Leukemia, B-Cell Primary Myelofibrosis |
Chronic Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Disease Attributes Pathologic Processes |