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

Lymphoma, B-Cell Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263583
• Other study ID #: PC002-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 9, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2022
• Source: Cothera Bioscience, Inc
• Contact: SeongSook Jung
• Phone: +82-2-6014-2000
• Email: Seong-sook.jung[@]ascent-dev.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: January 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

• Relapse or refractory disease after at least one previous line of therapy

• Measurable disease as defined by 2014 Lugano classification

• 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

Related Conditions & MeSH terms

• Burkitt Lymphoma
• High-grade B-cell Lymphoma
• Lymphatic Diseases
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, High-Grade
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Sepantronium Bromide
continuous intravenous infusion

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Sun Yat-sen University Cancer Center	Guangzhou
China	Henan Cancer Hospital	Henan
China	Shanghai East Hospital	Pudong
China	Tianjin Cancer Hospital	Tianjin
China	Tongji Hospital	Wuhan
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik hospital	Busan
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Cothera Bioscience, Inc

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability and recommended Phase 2 dose of sepantronium bromide	Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions	From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
Secondary	Overall response rate	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	From first dose through the last dose of study drug, an average of 6 months
Secondary	Complete response rate	Percentage of patients who experience a confirmed Complete Response at any time during the treatment phase	From first dose of study drug through the last dose of study drug, an average of 6 months
Secondary	Duration of response	Time from the first documentation of a Complete Response or a Partial Response until the time to objective tumor progression	From first dose of study drug through to time of progression, an average of 6 months
Secondary	Clinical benefit rate	Proportion of patients who achieve a Complete Response, Partial Response or Stable Disease during the treatment phase	From first dose of study drug through the last dose of study drug, an average of 6 months
Secondary	Overall survival	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	From first dose of study drug through date of death, irrespective of cause, an average of 6 months
Secondary	Progression Free Survival	The time from first dose until relapse, disease progression or death due to any cause	From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months