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Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia (INA03)

Primary Purpose

Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapse

Status
Recruiting
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
INA03 administration
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia Recurrent focused on measuring acute leukemia, refractory, in relapse, antibody drug conjugate, first in human, escalating doses, INA03

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

. Patient with

  • cytologically confirmed and documented B-cell or T-cell ALL or de novo, secondary or therapy-related AML or Mixed Phenotype Acute Leukemia (MPAL) defined according to World Health Organization (WHO) 2016 classification28 AND
  • with 20% or more CD71 positive blast cells
  • in relapse after- or refractory to registered therapies or ineligible to standard treatments
  • with circulating blasts ≤ 20 000/mm3. For eligible patients with AML/ALL with blasts > 20000/mm3, a treatment with hydroxyurea is allowed to maintain tumor cells ≤ 20000/mm3 2. Male or female age ≥ 18 years 3. WHO performance status 0-2 4. Following laboratory values unless considered due to the leukemia:

    1. AST and or ALT ≤ 2.5 ULN
    2. Total bilirubin level < 1.5 ULN (except Gilbert disease)
    3. Serum creatinine ≤ 1.5 ULN
    4. LDH < 3-5 ULN
    5. Uric acid ≤8 mg/dl
    6. Electrolyte panel within normal range
    7. Urine Dipstick Reading negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein ≤ 500 mg and measured creatinine clearance ≥50mL/min/1.73m2 from a 24-hour urine collection
    8. Patients who have recovered at least CTCAE grade <2 5. Life expectancy greater than 3 months 6. Women of child bearing potential must be willing to use birth control method during the study duration (W4 or early termination) plus 30 days. Male partner of women must use condom; in case of male patient, he must agree to use condom during the study duration (W4 or early termination) plus 30 days; 7. Pregnancy test (females of childbearing potential): negative 8. Signed informed consent indicating that they have been informed of the procedures to be followed, an is willing and able to comply the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts 9. Patient affiliated to the national "Social Security" regimen or beneficiary of this regi-men

      Exclusion Criteria:

      1. Patients with acute promyelocytic leukemia
      2. Patients with more than 30% marrow erythroid cells
      3. Patients who have been treated with any anti-TfR antibody
      4. Allogeneic stem cell transplantation in the last 6 months or with persistent active GVHD. Autologous bone marrow transplant in the last 3 months
      5. Last dose of prior chemotherapy, immunotherapy or investigational agent within 14 days or within 5 half-lives before baseline receipt of study medication, except for hydroxyurea and corticosteroids

      7. Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration 8. Patients who have history or clinical evidence of central nervous system (CNS), meningeal, or epidural disease from any cause and/or peripheral neuropathy 9. Impaired cardiac function or clinically significant cardiac disease, including any one of the following:

    a. New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant arrhythmia, congestive heart failure, or cardiomyopathy b. Angina pectoris ≤ 3 months prior to starting study drug c. Acute myocardial infarction ≤ 3 months prior to starting study drug d. Other clinically significant heart disease (e.g., uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) e. Left ventricular Ejection Fraction <45% 11. Uncontrolled infection 12. Acute and chronic liver disease 13. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnor-mality that may increase the risk associated with study participation or study drug administra-tion or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study.

    14. Patients with prior radiation therapy

    1. ≤12 weeks for cranial radiation therapy
    2. ≤ 4 weeks for wide field radiation therapy
    3. ≤2 weeks for involved field radiation therapy 15. Major surgery ≤ 4weeks prior to starting study drug or who have not recovered from side effects of such therapy 16. Known diagnosis of HIV infection (HIV testing is not mandatory). 17. History of another primary malignancy that is currently clinically significant or currently requires active intervention 18. Pregnant or breastfeeding patient; 19. Active drug or alcohol dependence; 20. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Sites / Locations

  • Institut Paoli-CalmettesRecruiting
  • IUCT

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INA03

Arm Description

INA03 administration

Outcomes

Primary Outcome Measures

Determination of the minimal erythroblastopenia-inducing dose (MEID) for INA03 in adults with refractory/relapsed acute leukemia
MEID defined as the lowest dose associated with the risks of residual erythroblasts in the bone marrow at 2 weeks from initial dosing or grade 2 or above non hematologic toxicity within 2 weeks from initial dosing
Determination of the maximum tolerated dose (MTD) for subsequent administrations (D15 from initial dosing and beyond) for INA03 in adults with refractory/relapsed acute leukemia
the maximum tolerated dose (MTD) for subsequent administrations (D15 from initial dosing and beyond)

Secondary Outcome Measures

Safety of INA03: NCI-CTCAE v5.0
Safety from the findings of reports of adverse events based on incidence, severity (as graded by the NCI-CTCAE v5.0), cumulative nature of treatment-emergent adverse event (TEAEs)
pharmacokinetic (PK) profile of INA03
Peak Plasma Concentration (Cmax) will be calculated, as appropriate
pharmacokinetic (PK) profile of INA03
Area under the plasma concentration versus time curve (AUC) will be calculated, as appropriate
pharmacokinetic (PK) profile of INA03
The terminal half-life will be calculated, as appropriate
pharmacodynamics (PD) profile of INA03
PD according to variation of erythroblast and blasts decrease using bone marrow as-pirate (BMA), and blood samples before and under treatment
Concentration of anti-INA03 antibodies
Serum concentration of anti-INA03 antibodies in micrograms per milliliter
Preliminary clinical response of INA03
Clinical response as defined by European LeukemiaNet (ELN) 2017 recommendations

Full Information

First Posted
May 6, 2019
Last Updated
February 14, 2023
Sponsor
Institut Paoli-Calmettes
Collaborators
INATHERYS
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1. Study Identification

Unique Protocol Identification Number
NCT03957915
Brief Title
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
Acronym
INA03
Official Title
A Phase I, First in Human, Open-label Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
INATHERYS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL. The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.
Detailed Description
This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL. The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukaemia Recurrent, Mixed Phenotype Acute Leukemia
Keywords
acute leukemia, refractory, in relapse, antibody drug conjugate, first in human, escalating doses, INA03

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Model Description
This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL. The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INA03
Arm Type
Experimental
Arm Description
INA03 administration
Intervention Type
Drug
Intervention Name(s)
INA03 administration
Intervention Description
INA03 will be administered IV on Day 1, Day 14 of 28-day cycles. The administration of INA03 will begin at 0.02 mg/kg. Study Part I is a titration study to determine the dose for the first INA03 infusion. Patients will be enrolled in sequential cohorts of 2 patients to receive ascending starting doses of INA03, starting from the lowest starting dose (0.02 mg/kg), and followed by subsequent administrations of INA03 (D14 and beyond) at a fixed dose of 0.1 mg/kg. The starting dose will be increased every cohort of 2 patients until evidence of absence of marrow residual erythroblasts by D14 myelogram. This dose is referred to as the MEID and will be selected as the D1 dose for the study Part 2. Patient accumulation in Part I of the study will continue until no evidence of non-hematological DLT within 28 days post dosing
Primary Outcome Measure Information:
Title
Determination of the minimal erythroblastopenia-inducing dose (MEID) for INA03 in adults with refractory/relapsed acute leukemia
Description
MEID defined as the lowest dose associated with the risks of residual erythroblasts in the bone marrow at 2 weeks from initial dosing or grade 2 or above non hematologic toxicity within 2 weeks from initial dosing
Time Frame
within 2 weeks from initial dosing
Title
Determination of the maximum tolerated dose (MTD) for subsequent administrations (D15 from initial dosing and beyond) for INA03 in adults with refractory/relapsed acute leukemia
Description
the maximum tolerated dose (MTD) for subsequent administrations (D15 from initial dosing and beyond)
Time Frame
28 days from the first administration of INA03
Secondary Outcome Measure Information:
Title
Safety of INA03: NCI-CTCAE v5.0
Description
Safety from the findings of reports of adverse events based on incidence, severity (as graded by the NCI-CTCAE v5.0), cumulative nature of treatment-emergent adverse event (TEAEs)
Time Frame
Until 30 days after last dose
Title
pharmacokinetic (PK) profile of INA03
Description
Peak Plasma Concentration (Cmax) will be calculated, as appropriate
Time Frame
From initial dosing day to Day 42
Title
pharmacokinetic (PK) profile of INA03
Description
Area under the plasma concentration versus time curve (AUC) will be calculated, as appropriate
Time Frame
From initial dosing day to Day 42
Title
pharmacokinetic (PK) profile of INA03
Description
The terminal half-life will be calculated, as appropriate
Time Frame
From initial dosing day to Day 42
Title
pharmacodynamics (PD) profile of INA03
Description
PD according to variation of erythroblast and blasts decrease using bone marrow as-pirate (BMA), and blood samples before and under treatment
Time Frame
From screening to end of study visit (maximum 182 days)
Title
Concentration of anti-INA03 antibodies
Description
Serum concentration of anti-INA03 antibodies in micrograms per milliliter
Time Frame
From screening to end of study visit (maximum 182 days)
Title
Preliminary clinical response of INA03
Description
Clinical response as defined by European LeukemiaNet (ELN) 2017 recommendations
Time Frame
from the date of treatment initiation (Day-1) to the date of relapse, progression or death, whichever comes first (a maximum 182 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: . Patient with cytologically confirmed and documented B-cell or T-cell ALL or de novo, secondary or therapy-related AML or Mixed Phenotype Acute Leukemia (MPAL) defined according to World Health Organization (WHO) 2016 classification28 AND with 20% or more CD71 positive blast cells in relapse after- or refractory to registered therapies or ineligible to standard treatments with circulating blasts ≤ 20 000/mm3. For eligible patients with AML/ALL with blasts > 20000/mm3, a treatment with hydroxyurea is allowed to maintain tumor cells ≤ 20000/mm3 2. Male or female age ≥ 18 years 3. WHO performance status 0-2 4. Following laboratory values unless considered due to the leukemia: AST and or ALT ≤ 2.5 ULN Total bilirubin level < 1.5 ULN (except Gilbert disease) Serum creatinine ≤ 1.5 ULN LDH < 3-5 ULN Uric acid ≤8 mg/dl Electrolyte panel within normal range Urine Dipstick Reading negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein ≤ 500 mg and measured creatinine clearance ≥50mL/min/1.73m2 from a 24-hour urine collection Patients who have recovered at least CTCAE grade <2 5. Life expectancy greater than 3 months 6. Women of child bearing potential must be willing to use birth control method during the study duration (W4 or early termination) plus 30 days. Male partner of women must use condom; in case of male patient, he must agree to use condom during the study duration (W4 or early termination) plus 30 days; 7. Pregnancy test (females of childbearing potential): negative 8. Signed informed consent indicating that they have been informed of the procedures to be followed, an is willing and able to comply the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts 9. Patient affiliated to the national "Social Security" regimen or beneficiary of this regi-men Exclusion Criteria: Patients with acute promyelocytic leukemia Patients with more than 30% marrow erythroid cells Patients who have been treated with any anti-TfR antibody Allogeneic stem cell transplantation in the last 6 months or with persistent active GVHD. Autologous bone marrow transplant in the last 3 months Last dose of prior chemotherapy, immunotherapy or investigational agent within 14 days or within 5 half-lives before baseline receipt of study medication, except for hydroxyurea and corticosteroids 7. Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration 8. Patients who have history or clinical evidence of central nervous system (CNS), meningeal, or epidural disease from any cause and/or peripheral neuropathy 9. Impaired cardiac function or clinically significant cardiac disease, including any one of the following: a. New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant arrhythmia, congestive heart failure, or cardiomyopathy b. Angina pectoris ≤ 3 months prior to starting study drug c. Acute myocardial infarction ≤ 3 months prior to starting study drug d. Other clinically significant heart disease (e.g., uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) e. Left ventricular Ejection Fraction <45% 11. Uncontrolled infection 12. Acute and chronic liver disease 13. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnor-mality that may increase the risk associated with study participation or study drug administra-tion or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study. 14. Patients with prior radiation therapy ≤12 weeks for cranial radiation therapy ≤ 4 weeks for wide field radiation therapy ≤2 weeks for involved field radiation therapy 15. Major surgery ≤ 4weeks prior to starting study drug or who have not recovered from side effects of such therapy 16. Known diagnosis of HIV infection (HIV testing is not mandatory). 17. History of another primary malignancy that is currently clinically significant or currently requires active intervention 18. Pregnant or breastfeeding patient; 19. Active drug or alcohol dependence; 20. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Genre, Dr
Phone
(00) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Margot Berline, MSc, MBA
Phone
04 91 22 33 14
Email
BERLINEM@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert VEY, Pr
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
State/Province
Bouches-du Rhône
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique GENRE, MD
Phone
+33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Norbert VEY
Facility Name
IUCT
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian RECHER

12. IPD Sharing Statement

Plan to Share IPD
No
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Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

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