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Study of IV CBL0137 in Previously Treated Hematological Subjects

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ClinicalTrials.gov Identifier: NCT02931110
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Incuron

Brief Summary:
This clinical trial is a Phase 1, open-label, sequential-group, dose-escalation (Part 1) and cohort-expansion study (Part 2) evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of CBL0137. The study will evaluate CBL0137 administered IV weekly on Days 1 and 8 of repeated 21 day treatment cycles in subjects with previously treated hematological malignancies.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Drug: CBL0137 Phase 1

Detailed Description:

Part 1 of the study will evaluate the safety and pharmacology of a range of CBL0137 doses administered IV in subjects with previously treated lymphomas, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), or Hodgkin lymphoma (HL).

Part 2 of the study provides cohort expansion to further explore the safety, pharmacology, and clinical activity of CBL0137 monotherapy in subjects with specific previously treated hematological cancers, including DLBCL, FL, MCL, HL, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and multiple myeloma (MM).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation and Cohort-Expansion Study of Intravenous CBL0137 in Subjects With Previously Treated Hematological Cancers
Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Experimental: CBL0137 Dose Escalation
  • Dose Level 1: 150mg/m2, IV
  • Dose Level 2: 180mg/m2, IV
  • Dose Level 3: 240mg/m2, IV
  • Dose Level 4: 320mg/m2, IV
  • Dose Level 5: 400mg/m2, IV
  • Dose Level 6: 540mg/m2, IV
  • Dose Level 7: 700mg/m2, IV
  • Dose Level 8: 920mg/m2, IV
  • Dose Level 9: 1200mg/m2, IV
  • Dose Level 10: 1600mg/m2, IV
  • Dose Level 11: 2100mg/m2, IV
  • Dose Level 12: 2700mg/m2, IV
Drug: CBL0137
All dose are on Days 1 and 8 of every 22 day cycle. Number of Cycles: 2 or until progression or unacceptable toxicity develops




Primary Outcome Measures :
  1. Maximally tolerated dose and recommended Phase 2 does in patients with hematological malignancy [ Time Frame: 30 days after last dose ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of an active hematological malignancy:

    • Part 1 (Dose Escalation): Diagnosis of B-cell DLBCL, FL, MCL, HL, CLL/SLL or MM as documented by medical records.
    • Part 2 (Cohort Expansion): Diagnosis of DLBCL, FL, MCL, HL, CLL/SLL, ALL, MM, or AML as documented in medical records.
  • Requirement for therapy of the hematological malignancy due to disease-related symptoms, lymphadenopathy, organomegaly, extranodal organ involvement, or progressive disease.
  • Hematological malignancy has been previously treated, has relapsed after or progressed during prior therapy, and has limited potential for benefit from currently available therapy, including hematopoietic stem cell transplantation.
  • Presence of measurable disease:

    • For subjects with DLBCL, FL, MCL, HL, or CLL/SLL: presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 lesion that measures ≥2.0 cm in the longest dimension [LD] and ≥1.0 cm in the longest perpendicular dimension [LPD] as assessed by computed tomography [CT]).
    • For subjects with MM, measurable disease with serum monoclonal immunoglobulin protein (M-protein) ≥1 g/dL, or urine M-protein protein ≥200 mg/24 hours, or involved serum free light chain (SFLC) ≥10 mg/dL.
    • For subjects with ALL or AML, presence of >5% blasts in the bone marrow (based on a bone marrow aspirate/biopsy sample with ≥200 nucleated cells and the presence of bone marrow spicules) and/or >1 x 109/L blasts in the peripheral blood (with the restriction that peripheral blast count in subjects with AML must be <50 x 109/L prior to the start of study therapy).

Exclusion Criteria:

  • Rapidly progressive, clinically unstable central nervous system hematological malignancy. Note: Central nervous system evaluation is only required in subjects with known or suspected central nervous system malignancy.
  • Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months prior to start of study therapy; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy; or history of congenital prolonged QT syndrome.
  • Significant screening ECG abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation/flutter, left bundle-branch block, 2nd-degree atrioventricular (AV) block type II, 3rd degree AV block, Grade ≥2 bradycardia, or QT corrected for heart rate (QTc) >450 msec (for men) or >470 msec (for women).
  • Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis or requirement for systemic anticoagulation with unfractionated heparin, low-molecular-weight heparin or heparin fractions (eg, enoxaparin, dalteparin, fondaparinux) or oral anticoagulants (eg, apixaban, rivaroxaban, dabigatran etexilate, warfarin). Note: Use of heparin or thrombolytic agents for local maintenance or clearance of a central venous catheter is permitted.
  • Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of study therapy. Note: Subjects with localized fungal infections of skin or nails are eligible.

Please speak with Investigator for the complete Inclusion/Exclusion criteria.


Information from the National Library of Medicine

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): NCT02931110


Contacts
Contact: Langdon L Miller, MD 716-849-6814 ext 301 lmiller@cbiolabs.com
Contact: Yakov Kogan, Ph.D 716-849-6810

Locations
United States, Georgia
Claude Sportes Recruiting
Augusta, Georgia, United States, 30912
Contact: Claude Sportes, MD    706-721-2505    csportes@augusta.edu   
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Francisco J Hernandez, MD       Fhernandez@roswellpark.org   
Principal Investigator: Francisco J Hernandez, MD         
United States, Ohio
University Hospitals Case Medical Recruiting
Cleveland, Ohio, United States, 44106
Contact: Paolo F Caimi, MD         
Principal Investigator: Paolo F Caimi, MD         
Sponsors and Collaborators
Incuron
Investigators
Study Director: Langdon Miller, MD Cleveland BioLabs, Inc.

Responsible Party: Incuron
ClinicalTrials.gov Identifier: NCT02931110     History of Changes
Other Study ID Numbers: I137-102
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Incuron:
Diffuse large B-cell lymphoma (DLBCL)
follicular lymphoma (FL)
mantle cell lymphoma (MCL)
Hodgkin lymphoma (HL)
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
Multiple myeloma (MM)