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Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma

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ClinicalTrials.gov Identifier: NCT04853329
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Conjupro Biotherapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 2, 2021
First Posted Date  ICMJE April 21, 2021
Last Update Posted Date August 10, 2022
Actual Study Start Date  ICMJE December 13, 2021
Estimated Primary Completion Date December 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2021)
To determine the recommended single-agent CPO107 RP2D [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2021)
  • Safety assessment-Incidence of treatment-emergent AEs (TEAEs) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: through study completion, an average of 1 year ]
    To document any early indication of clinical efficacy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma
Official Title  ICMJE Phase 1/2, Multicenter, First-In-Human, Dose Escalation and Dose Expansion Study of CPO107 Administered Intravenously to Patients With Advanced CD20-positive Non-Hodgkins Lymphoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CD20 Positive Non Hodgkin Lymphoma
Intervention  ICMJE Drug: CPO107
CD20-CD47 Bispecific Fusion Protein
Other Name: JMT601
Study Arms  ICMJE
  • Experimental: PartA- Arm A

    Arm A 1-6 subjects will be enrolled at dose levels of CPO107 at (1, 3, 6, 12, 20 mg/kg).

    Each subject group will receive multiple cycles of a weekly dose of CPO-107 (1 cycle=21 days=3 treatments).

    Intervention: Drug: CPO107
  • Experimental: PartA- Arm B
    Arm B will explore a 3 weekly schedule in which a single dose is administered every 3 weeks (1 cycle=21 days=1 treatment). The starting dose for Arm B will be the dose level below the Arm A level that provides an equivalent dose over a 3-week period.
    Intervention: Drug: CPO107
  • Experimental: Part B
    Part B with either: second or greater relapse OR refractory patients, as defined by not achieving a CR after 2 cycles of a standard first line chemoimmunotherapy regimen or not achieving a CR following 1 cycle of a second line chemotherapy regimen.
    Intervention: Drug: CPO107
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2021)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2024
Estimated Primary Completion Date December 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Exclusion Criteria:

The following key exclusion criteria apply:

  • Patients with indolent Follicular Lymphoma or Chronic/Small/Prolymphocytic/Mantle B-cell non-Hodgkin lymphoma in need of immediate cytoreductive therapy are excluded, unless the patient has no remaining treatment choice with potential benefit.
  • Patient has participated in any investigational research study and is being screened for participation within a period of 5 half-lives, or 4 weeks of the last dose of the investigational therapy, whichever is longer.
  • Patients with history of severe hypersensitivity reactions to anti-CD20 treatment or any components of study drug formulation.
  • Presence or recent history within 6 months of arteritis or any systemic clotting disorder, thrombotic or thromboembolic events.
  • History or presence of autoimmune conditions; patients who have a medical condition that requires chronic systemic steroid therapy or requires any other form of immunosuppressive medication.
  • Patients with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Fredericia's QT correction formula.
  • Active or latent hepatitis B or active hepatitis C or any uncontrolled infection at screening; HIV positive test within 8 weeks of screening.
  • Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • Presence of other active cancers, or history of treatment for invasive cancer ≤3 years.
  • Patients who started erythropoietin or granulocyte colony-stimulating factor (G-CSF), pegfilgrastim, or filgrastim ≤4 weeks prior to the first dose of the study drug.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Active CNS disease involvement; CNS directed radiation must be completed >8 weeks prior to CPO107 infusion.
  • Non-CNS site of radiation must be completed >2 weeks prior to CPO107 infusion.
  • Pregnant or nursing (lactating) women
  • And others
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kevin Romanko 609-686-6502 clinicaltrials.gov@cspcus.com
Contact: Audrey Li 609-356-0210 clinicaltrials.gov@cspcus.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04853329
Other Study ID Numbers  ICMJE CPO107-US-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Undecided
Current Responsible Party Conjupro Biotherapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Conjupro Biotherapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steven Novick, MD PhD Conjupro Biotherapeutics, Inc.
PRS Account Conjupro Biotherapeutics, Inc.
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP