CD20 Positive Non Hodgkin Lymphoma
Conditions
Keywords
CD20 positive, Non Hodgkin Lymphoma, CD20 CD47, CPO107, Phase 1
Brief summary
This first-in-human Phase 1 study will be a multicenter, dose-escalating, single-agent study conducted in patients with advanced CD20-associated hematological cancers for which the investigator determines there to be no other higher priority therapies available.
Detailed description
This first-in-human Phase 1 study will be a multicenter, dose-escalating, single-agent study conducted in patients with advanced CD20-associated hematological cancers for which the investigator determines there to be no other higher priority therapies available. All patients must have failed at least two prior lines of conventional systemic therapy that must also include an approved CD20 based treatment. All patients will need to have CD20-positive disease, as determined by the expression of CD20 on tumor cells assayed within 6 months prior to study entry. The study will consist of 2 parts, Part A and Part B. In Part A of the study, dose escalation will proceed according to the guidelines in the Treatment and Dosing section below, following a rule-based design methodology. Two different schedules will be explored to establish the PK profile and thus better inform the selection of the final dosing schedule to be developed. Arm A will explore a continuous weekly dosing schedule and will commence first. Arm B will explore a 3 weekly schedule in which a single dose is administered every 3 weeks. Part B dose expansion of the study will commence, in which a single dosing schedule will be explored in CD20-positive patients. The schedule will be selected based on PK and safety determinants from Study Part A. NOTE: Trial was intended to be a Phase 1/2 trial, however the trial only enrolled patients in Study Part A (Phase 1) and was subsequently terminated early for business reasons.
Interventions
DRUGCPO107
CD20-CD47 Bispecific Fusion Protein
Sponsors
Conjupro Biotherapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following key inclusion criteria apply to both Part A and Part B: * Diagnosis of CD20 positive NHL. CD20 assay to have been performed within 6 months prior to protocol entry. Eligible NHL subtypes include Diffuse Large B-Cell Lymphoma (DLBCL, not otherwise specified, NOS), Follicular Lymphoma, Chronic lymphocytic leukemia/small lymphocytic lymphoma, B cell prolymphocytic leukemia and Mantle cell lymphoma. * Patients with SLL must have received, or not be eligible for, BTK and BCL-2 inhibitor therapy. * Disease progression or relapse following at least two prior lines of conventional systemic therapy for advanced disease. Dosing regimen must have included a CD20 targeted therapy (for example, RCHOP). * A clinical indication for treatment must be present for patients with Follicular Lymphoma and Chronic/Small/Prolymphocytic/Mantle B-cell non-Hodgkin lymphoma. * Having at least one measurable target lesion present and documented by RECIST 1.1. * Adequate organ function, such as Renal function, Hepatic Function, Cardiovascular, Adequate hematological reserve. * Complete resolution of all prior toxicities from prior anticancer therapy, defined as having resolved to baseline or to common terminology criteria for adverse events (CTCAE) grade≤1, with the exception of alopecia, or to the levels dictated in the inclusion/
Exclusion criteria
, and a washout period of 5 half-lives of prior small molecule systemic therapy. * Life expectancy \>12 weeks. * Age: Lower age limit of 18 years. * ECOG performance status 0 or 1 at screening. * Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent. For minors, legal guardian willingness to give written informed consent with patient assent, where appropriate. * Patients of reproductive potential: All female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the recommended single-agent CPO107 RP2D | through study completion, an average of 1 year | To determine the recommended single-agent CPO107 RP2D and schedule for further exploration in CD20 positive Non-Hodgkins Lymphoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment-Incidence of treatment-emergent AEs (TEAEs) | through study completion, an average of 1 year | Safety will be assessed through the analysis of the reported incidence of treatment-emergent AEs (TEAEs) by evaluating adverse events based on laboratory results, vital signs and ECG findings. |
| Pharmacokinetic (PK) | through study completion, an average of 1 year | The pharmacokinetic of CPO-107 will be assessed by measuring the blood concentration of the drug in the plasma at various timepoints and calculation of parameters, such as Peak Plasma Concentration (Cmax). |
| Expression of anti-drug antibody (ADA) | through study completion, an average of 1 year | The expression of anti-drug antibodies (ADAs) following administration will be assessed by analysis of serum samples. |
| Efficacy assessment | through study completion, an average of 1 year | To document any early indication of clinical efficacy. |
Countries
United States
Contacts
STUDY_DIRECTORSteven Novick, MD PhD
Conjupro Biotherapeutics, Inc.
Outcome results
None listed