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A Beta-only IL-2 ImmunoTherapY (ABILITY) Study

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ClinicalTrials.gov Identifier: NCT05086692
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Medicenna Therapeutics, Inc.

Brief Summary:
This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Unresectable Solid Tumor Melanoma Renal Cell Carcinoma Sarcoma Triple Negative Breast Cancer Pancreatic Ductal Adenocarcinoma Non-Small Cell Lung Cancer Squamous Non-Small Cell Lung Cancer Non-squamous Colorectal Cancer Gastric Cancer Biliary Tract Cancer Gallbladder Cancer Cholangiocarcinoma Uterine Cancer Ovarian Cancer Cervical Cancer Basal Cell Carcinoma Bladder Cancer Merkel Cell Carcinoma Squamous Cell Carcinoma of Head and Neck Cutaneous Squamous Cell Carcinoma Drug: MDNA11 Monotherapy Drug: MDNA11 in combination with checkpoint inhibitor Phase 1 Phase 2

Detailed Description:

The study drug, MDNA11, is a selective IL-2 preferentially activating effector T cells (naïve CD8+ T-cells) and NK cells responsible for killing cancer cells, with minimal or no stimulation of the immunosuppressive Tregs. It is designed to potentially enhance host immune response and fusion to albumin increases the half-life further avoiding frequent dosing required with rhIL-2.

The study will be conducted at approximately 12 clinical sites following regulatory authority and institutional review board / independent ethics committee (IRB/ IEC) approval and completion of informed consent. The study will be conducted in two parts:

  • Sequential Dose Escalation
  • Dose Expansion in monotherapy as well as with an immune checkpoint inhibitor.

Approximately 80 patients will be enrolled.

Tumor assessment by CT/MRI will be performed every 12 weeks and will continue until documented disease progression. Treatment may continue for up to 1 year, or until treatment discontinuation criteria are met. Patients can withdraw from participation at any time.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential dose escalation (MDNA11 monotherapy) followed by dose expansion with MDNA11 monotherapy as well as in combination with a CPI.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : December 30, 2024


Arm Intervention/treatment
Experimental: MDNA11
MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion
Drug: MDNA11 Monotherapy

MDNA11 will be administered by the IV route on a once every 2 weeks (Q2W) dosing schedule.

Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the Recommended Phase 2 Dose (RP2D)

Other Name: Interleukin-2 (IL-2)-albumin

Drug: MDNA11 in combination with checkpoint inhibitor
MDNA11 in combination with checkpoint inhibitor Combination cohort is planned to evaluate the safety/ tolerability and anti-tumor activity of single agent MDNA11, or in combination with CPI in patients with solid tumors




Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) for MDNA11 [ Time Frame: 12 months ]
    Evaluation of tolerability as measured by number of patients with dose limiting toxicities (DLTs)

  2. Incidence of Treatment Related Adverse Events (TRAEs) [ Time Frame: 12 months ]
    Rate of TRAEs in patients with advanced solid tumors

  3. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 months ]
    Rate of TEAEs in patients with advanced solid tumors


Secondary Outcome Measures :
  1. Pharmacokinetic characteristics on MDNA11 - Cmax (ug/mL) [ Time Frame: Up to 12 months ]
    Maximum observed serum drug concentration

  2. Pharmacokinetic characteristics on MDNA11 - Tmax (h) [ Time Frame: Up to 12 months ]
    Time to maximum observed serum drug concentration

  3. Pharmacokinetic characteristics on MDNA11 - AUClast (h.ug/mL) [ Time Frame: Up to 12 months ]
    Area under the serum concentration vs time curve from time zero to the last measurable concentration

  4. Pharmacodynamic effects of MDNA11 [ Time Frame: Up to 12 months ]
    Measurement of translational parameters - Flow cytometry analysis of immune cells in blood

  5. Pharmacodynamic effects of MDNA11 [ Time Frame: Up to 12 months ]
    Measurement of translational parameters - Serum measurements of cytokine levels

  6. Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Overall Response Rate (ORR) [ Time Frame: Approximately 12 months ]
    Assessed by RECIST v1.1; CR+PR/Evaluable N

  7. Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Disease Control Rate (DCR) [ Time Frame: Approximately 12 months ]
    CR+PR+SD/Evaluable N

  8. Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Progression Free Survival (PFS) [ Time Frame: Approximately 12 months ]
    Time from signing ICF to disease progression


Other Outcome Measures:
  1. Analysis of immune characteristics of the tumor microenvironment [ Time Frame: Up to 12 months ]
    Measured by change in Tumor Infiltrating Lymphocyte (TIL) levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male Female (Women of Childbearing Potential will be subject to pregnancy testing)
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Aged at least 18 years (inclusive at the time of informed consent).
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
  4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor that is unresectable (see tumor types listed under conditions)
  5. Demonstrated adequate organ function
  6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.
  7. Life expectancy of ≥ 12 weeks.
  8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.
  9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control

Key Exclusion Criteria:

  1. Received anticancer therapy within 28 days prior to the first dose of study drug(s).
  2. Has carcinomatous meningitis or leptomeningeal disease; stable CNS metastases permitted based on Medical Monitor review.
  3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers
  4. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.
  5. Severe pulmonary, cardiac or other systemic disease.
  6. Females who are pregnant or lactating or planning to become pregnant during the study.
  7. Active infection requiring systemic therapy.
  8. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol
  9. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.
  10. Known severe hypersensitivity to any component of study drug(s).
  11. Prior Interleukin therapy.
  12. Inability to comply with study and follow up procedures as judged by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086692


Contacts
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Contact: Nina Merchant 604-340-3081 nmerchant@medicenna.com
Contact: Melissa Coello 267-476-2313 mcoello@medicenna.com

Locations
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Australia, New South Wales
Chris O'Brien Lifehouse Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Scientia Clinical Research Recruiting
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Gallipoli Medical Research Foundation Recruiting
Greenslopes, Queensland, Australia, 4120
ICON Cancer Center Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Cabrini Research Recruiting
Malvern, Victoria, Australia, 3144
Sponsors and Collaborators
Medicenna Therapeutics, Inc.
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Responsible Party: Medicenna Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05086692    
Other Study ID Numbers: MDNA11-01
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medicenna Therapeutics, Inc.:
IL-2
IL2
Interleukin-2
cancer
metastatic
RCC
TNBC
PDA
NSCLC
CRC
GEJ
intrahepatic
extrahepatic
MCC
SCCHN
CSCC
Gastroesophageal Junction
advanced
unresectable
Cholangiocarcinoma
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma
Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Triple Negative Breast Neoplasms
Cholangiocarcinoma
Carcinoma, Basal Cell
Biliary Tract Neoplasms
Gallbladder Neoplasms
Uterine Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Squamous Cell
Adenocarcinoma