Clincosm LogoSign in Get a demo

Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma

Sponsor
Cothera Bioscience, Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05263583
Collaborator
(none)
18
Enrollment
6
Locations
3
Arms
22
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center Phase 2 study to determine the safety and efficacy of sepantronium bromide (SepB) in adult patients with relapsed or refractory high-grade B-cell lymphoma

Condition or Disease Intervention/Treatment Phase
  • Drug: Sepantronium Bromide
 Phase 2

Detailed Description

This is a multi-center, open label, dose-ranging Phase 2 study evaluating the safety and efficacy of SepB in patients with relapsed/refractory c-Myc rearranged HGBCL.

Cohorts of three patients will be enrolled at each dose level for SepB with expansion to six patients, if necessary, to assess toxicity.

Following the completion of 2 cycles of treatment of each cohort, an independent Data Monitoring Committee (DMC) will review the safety data to assess study drug related toxicities from the current cohort. Following this review, a decision will be made to continue dose escalation to the next dose level, to declare that a given dose level is the level of dose-limiting toxicity (DLT) or to further explore toxicity at the dose level in question by enrolling additional subjects to a maximum of six subjects at that level.

An additional 6 patients will be enrolled at the recommended Phase 2 dose (RP2D). The RP2D will be established on the basis of the maximally tolerated dose between the two specified dose levels as well as other relevant data, including clinical signals of activity, pharmacokinetic (PK) and pharmacodynamic (PD) data.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Dose range findings studyDose range findings study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Open Label Dose-ranging Study of Sepantronium Bromide in Patients With Relapsed/Refractory c-Myc Rearranged High-grade B-cell Lymphoma (HGBCL)
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide

Drug: Sepantronium Bromide
continuous intravenous infusion
Other Names:
  • PC-002

    		•
    Experimental: Cohort 2

    Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide

    Drug: Sepantronium Bromide
    continuous intravenous infusion
    Other Names:
  • PC-002

    		•
    Experimental: Recommended Phase 2 Dose - Cohort 3

    The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2

    Drug: Sepantronium Bromide
    continuous intravenous infusion
    Other Names:
  • PC-002

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability and recommended Phase 2 dose of sepantronium bromide [From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months]

      Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions

    Secondary Outcome Measures

    1. Overall response rate [From first dose through the last dose of study drug, an average of 6 months]

      The ORR is defined as the percentage of participants who achieve either a Partial Response or Complete Response at any time during the treatment phase

    2. Complete response rate [From first dose of study drug through the last dose of study drug, an average of 6 months]

      Percentage of patients who experience a confirmed Complete Response at any time during the treatment phase

    3. Duration of response [From first dose of study drug through to time of progression, an average of 6 months]

      Time from the first documentation of a Complete Response or a Partial Response until the time to objective tumor progression

    4. Clinical benefit rate [From first dose of study drug through the last dose of study drug, an average of 6 months]

      Proportion of patients who achieve a Complete Response, Partial Response or Stable Disease during the treatment phase

    5. Overall survival [From first dose of study drug through date of death, irrespective of cause, an average of 6 months]

      The time from the first dose of study drug until death from any cause or date of last follow-up for living and lost to follow-up patients

    6. Progression Free Survival [From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months]

      The time from first dose until relapse, disease progression or death due to any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Confirmed histologic diagnosis of c-Myc rearranged high-grade B-cell lymphoma

    • Relapse or refractory disease after at least two previous lines of therapy

    • Measurable disease as defined by RECIL criteria

    • ECOG performance status of 0-2

    • Acceptable coagulation parameters

    Exclusion Criteria:

    • Allogeneic transplant within 3 months

    • Autologous transplant without resolution of post-transplant cytopenias

    • Known CNS involvement

    • Average QT/QTc interval duration > 450 msec

    • Inadequate marrow, hepatic or renal function

    • Unresolved Grade 2 or greater toxicities from prior anticancer therapy

    • Radiotherapy within prior 4 weeks

    • Requires systemic immunosuppressive therapy

    • Positive for Hepatis B or Hepatis C

    • Seropositive for HIV

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dong-A University Hospital Busan Korea, Republic of
    2 Inje University Haeundae Paik hospital Busan Korea, Republic of
    3 Samsung Medical Center Seoul Korea, Republic of
    4 Seoul National University Hospital Seoul Korea, Republic of
    5 Seoul St.Mary's Hospital Seoul Korea, Republic of
    6 Yonsei Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Cothera Bioscience, Inc

    Investigators

    • Study Director: Vernon Jiang, PhD, Cothera Bioscience

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cothera Bioscience, Inc
    ClinicalTrials.gov Identifier:
    NCT05263583
    Other Study ID Numbers:
    • PC002-01
    First Posted:
    Mar 2, 2022
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cothera Bioscience, Inc
    Relapsed/refractory
    Additional relevant MeSH terms:
    Burkitt Lymphoma
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse
    Lymphoma, Non-Hodgkin
    Lymphatic Diseases
    Bromides

    Study Results

    No Results Posted as of Mar 2, 2022