NCT02440685

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

Geographic Reach
2 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

June 7, 2023

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

3.1 years

First QC Date

May 5, 2015

Results QC Date

April 13, 2023

Last Update Submit

May 15, 2023

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, FollicularCancerNeoplasmTumorLymphoma, MalignantLymphoma, B-cellLymphoma, Non-HodgkinB-Cell Chronic Lymphocytic LeukemiaB-Cell Leukemia, ChronicB-Lymphocytic Leukemia, ChronicChronic Lymphocytic LeukemiaLeukemia, Lymphocytic, ChronicLeukemia, Lymphocytic, Chronic, B CellMyelofibrosisChronic Idiopathic MyelofibrosisIdiopathic MyelofibrosisLymphoma, T Cell, PeripheralPeripheral T-Cell LymphomaT-Cell Lymphoma, Peripheral

Keywords

DLBCLFLMCLPTCLMFCLL

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    Due to the early termination of the study, data for efficacy endpoints were insufficient for the planned efficacy analyses.

    First 29 days

Study Arms (2)

Part A ASN002 Dose Escalation

EXPERIMENTAL

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

Drug: ASN002 Dose Escalation

Part B ASN002 Recommended dose (RD)

EXPERIMENTAL

ASN002 administered at the recommended dose

Drug: ASN002 RD

Interventions

ASN002 Dose EscalationDRUG

Multiple ascending doses of ASN002 assigned by cohort

Part A ASN002 Dose Escalation
ASN002 RDDRUG

Recommended dose of ASN002 from Part A

Part B ASN002 Recommended dose (RD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Arizona Oncology

Tempe, Arizona, 85284, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Winship Cancer Institute - Emory

Atlanta, Georgia, 30322, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

START - Midwest

Grand Rapids, Michigan, 49546, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Hospital Universitario Austral

Buenos Aires, Derqui, Pilar, 1629, Argentina

Location

Instituto Alexander Fleming

Buenos Aires, 1426, Argentina

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, FollicularNeoplasmsLymphomaLymphoma, B-CellLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellPrimary MyelofibrosisLymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyeloproliferative DisordersBone Marrow DiseasesLymphoma, T-Cell

Results Point of Contact

Title
Niranjan Rao
Organization
Libertas BioSciences
niranjan@libertasbiosciences.com
908-872-1133

Study Officials

  • Niranjan Rao, PhD

    Asana BioSciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study terminated early so no all groups per protocol were conducted
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 12, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

June 7, 2023

Results First Posted

June 7, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

AR(2)US(12)