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NCT02440685 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2023-06-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Multiple ascending doses of ASN002 will be administered to determine the maximum tolerated dose (MTD). Arm Closed
    intervention Names
    1. Drug: ASN002 Dose Escalation
    label
    Part A ASN002 Dose Escalation
    type
    EXPERIMENTAL
  2. description
    ASN002 administered at the recommended dose
    intervention Names
    1. Drug: ASN002 RD
    label
    Part B ASN002 Recommended dose (RD)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part A ASN002 Dose Escalation
    description
    Multiple ascending doses of ASN002 assigned by cohort
    name
    ASN002 Dose Escalation
    type
    DRUG
  2. arm Group Labels
    1. Part B ASN002 Recommended dose (RD)
    description
    Recommended dose of ASN002 from Part A
    name
    ASN002 RD
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
intervention Model Description
Study terminated early so no all groups per protocol were conducted
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
51
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Due to the early termination of the study, data for efficacy endpoints were insufficient for the planned efficacy analyses.
    measure
    Objective Response Rate
    time Frame
    First 29 days
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-3d37a444825874389a9f
      requested nct id
      NCT02440685
      primary nct id
      NCT02440685
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      4ea81f1e680e8b7859da52aa571aa69706ef94ccef1d93968b72119699db20ca
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-3d37a444825874389a9f
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02440685
      occurrences
      1. context exact
        NCT02440685
        end
        11
        exact text
        NCT02440685
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/82/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      c11219d7cb0762f7c8ef3efa5929b7d4418fb88d02364eabbaff03166042eb55

    Preserved source evidence · Not medical advice