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

Phase 2Active Not RecruitingNCT05263583

Cothera Bioscience, Inc14 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High-grade B-cell Lymphoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (11)

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, China

Dong-A University Hospital

Busan, South Korea

Inje University Haeundae Paik hospital

Busan, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

...and 1 more locations

Outcomes

Primary Outcomes

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

Time frame: From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months

Secondary Outcomes

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

Time frame: From first dose through the last dose of study drug, an average of 6 months

Complete response rate

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

Time frame: From first dose of study drug through the last dose of study drug, an average of 6 months

Duration of response

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

Time frame: From first dose of study drug through to time of progression, an average of 6 months

Clinical benefit rate

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

Time frame: From first dose of study drug through the last dose of study drug, an average of 6 months

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

Time frame: From first dose of study drug through date of death, irrespective of cause, an average of 6 months

Progression Free Survival

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

Time frame: From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months