Lymphoma, Large B-Cell, DiffusePhase 1/2NCT02440685
A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors
A Phase 1/2 study testing ASN002 Dose Escalation and ASN002 RD in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, Mantle-Cell, run by Asana BioSciences at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular
- What is being tested?
- ASN002 Dose Escalation and ASN002 RD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 14 sitesin 2 countries
- Study dates
- May 2015to Jul 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
University of Michigan
Ann Arbor, Michigan, 48109
Winship Cancer Institute - Emory
Atlanta, Georgia, 30322
Gabrail Cancer Center
Canton, Ohio, 44718
Virginia Cancer Specialists
Fairfax, Virginia, 22031
START - Midwest
Grand Rapids, Michigan, 49546
MD Anderson Cancer Center
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health & Science University
Portland, Oregon, 97239
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94143
Arizona Oncology
Tempe, Arizona, 85284
Argentina2 sites
Hospital Universitario Austral
Buenos Aires, Derqui, Pilar, 1629
Instituto Alexander Fleming
Buenos Aires, 1426
About this study
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
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.
Read the 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
- Being tested
- ASN002 Dose Escalation, ASN002 RD
- Keywords
- DLBCL, FL, MCL, PTCL, MF, CLL
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Neoplasms, Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASN002 Dose EscalationDrug
Multiple ascending doses of ASN002 assigned by cohort
ASN002 RDDrug
Recommended dose of ASN002 from Part A
| Study group | Role | What they receive |
|---|---|---|
| Part A ASN002 Dose Escalation | Experimental | Multiple ascending doses of ASN002 will be administered to determine the maximum tolerated dose (MTD). Arm Closed Receives: Drug: ASN002 Dose Escalation |
| Part B ASN002 Recommended dose (RD) | Experimental | ASN002 administered at the recommended dose Receives: Drug: ASN002 RD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Due to the early termination of the study, data for efficacy endpoints were insufficient for the planned efficacy analyses.
Measured: First 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2018
- Study completionJul 2018
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Study terminated early so no all groups per protocol were conducted
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asana BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niranjan Rao, PhD, Study director, Asana BioSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440685
- Sponsor's protocol ID
- ASN002-101
- Status last verified
- May 2023
- First submitted
- 5 May 2015
- Last updated
- 7 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02440685
- Acronym / sponsor ID
- ASN002-101
- Conditions
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Cancer, Neoplasm, Tumor
- Keywords
- DLBCL, FL, MCL, PTCL, MF, CLL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Asana BioSciencesIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Posted 7 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study terminated early so no all groups per protocol were conducted
| Arm | Type | Receives |
|---|---|---|
| Part A ASN002 Dose Escalation | Experimental | Drug: ASN002 Dose EscalationMultiple ascending doses of ASN002 will be administered to determine the maximum tolerated dose (MTD). Arm Closed |
| Part B ASN002 Recommended dose (RD) | Experimental | Drug: ASN002 RDASN002 administered at the recommended dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASN002 Dose EscalationMultiple ascending doses of ASN002 assigned by cohort | Drug | Part A ASN002 Dose Escalation |
| ASN002 RDRecommended dose of ASN002 from Part A | Drug | Part B ASN002 Recommended dose (RD) |
Primary outcome
Objective Response Rate
Time frame: First 29 days
Due to the early termination of the study, data for efficacy endpoints were insufficient for the planned efficacy analyses.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niranjan Rao, PhD study director
Asana BioSciences
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ASN002 Dose Escalation and ASN002 RD in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, Mantle-Cell, run by Asana BioSciences at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: First 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.