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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05086692




Registration number
NCT05086692
Ethics application status
Date submitted
10/09/2021
Date registered
21/10/2021

Titles & IDs
Public title
A Beta-only IL-2 ImmunoTherapY Study
Scientific 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
Secondary ID [1] 0 0
KEYNOTE-E53
Secondary ID [2] 0 0
MDNA11-01
Universal Trial Number (UTN)
Trial acronym
ABILITY-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Unresectable Solid Tumor 0 0
Clear Cell Renal Cell Carcinoma 0 0
Triple Negative Breast Cancer 0 0
Non-Small Cell Lung Cancer Squamous 0 0
Non-Small Cell Lung Cancer Non-squamous 0 0
Colorectal Cancer (MSI-H) 0 0
Gastric Cancer 0 0
Cervical Cancer 0 0
Basal Cell Carcinoma 0 0
Bladder Cancer 0 0
Merkel Cell Carcinoma 0 0
Squamous Cell Carcinoma of Head and Neck 0 0
Cutaneous Squamous Cell Carcinoma 0 0
Pleural Mesothelioma 0 0
Esophageal Cancer 0 0
Endometrial Carcinoma 0 0
Solid Tumor 0 0
Solid Tumor, Adult 0 0
MSI-H Solid Malignant Tumor 0 0
Cancer With A High Tumor Mutational Burden 0 0
Epithelial Ovarian Carcinoma 0 0
Primary Peritoneal Cancer 0 0
Gastroesophageal Junction (GEJ) Cancer 0 0
Acral Melanoma 0 0
Mucosal Melanoma 0 0
Cutaneous Melanoma 0 0
DMMR Solid Malignant Tumor 0 0
Fallopian Tube Cancer 0 0
Ovarian Cancer 0 0
MSI-H Cancer 0 0
DMMR Cancer 0 0
Pancreas Adenocarcinoma (MSI-H) 0 0
Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MDNA11
Treatment: Drugs - Pembrolizumab (KEYTRUDA®)

Experimental: MDNA11 - MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion


Treatment: Drugs: MDNA11
MDNA11 will be administered, IV 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 monotherapy Recommended Dose for Expansion (mRDE).

Treatment: Drugs: Pembrolizumab (KEYTRUDA®)
MDNA11 will be administered in combination with pembrolizumab, IV. MDNA11 dose range to be evaluated in combination with pembrolizumab until determining the combination Recommended Dose for Expansion (cRDE).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE)
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Incidence of Treatment Related Adverse Events (TRAEs)
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Incidence of Treatment Emergent Adverse Events (TEAEs)
Timepoint [3] 0 0
24 months
Secondary outcome [1] 0 0
Pharmacokinetic characteristics on MDNA11 - Cmax (ug/mL)
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Pharmacokinetic characteristics on MDNA11 - Tmax (h)
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Pharmacokinetic characteristics on MDNA11 - AUClast (h.ug/mL)
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Immunogenicity of MDNA11 (anti-drug antibodies)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Pharmacodynamic effects of MDNA11
Timepoint [5] 0 0
Up to 24 months
Secondary outcome [6] 0 0
Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Overall Response Rate (ORR)
Timepoint [6] 0 0
Approximately 24 months
Secondary outcome [7] 0 0
Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Disease Control Rate (DCR)
Timepoint [7] 0 0
Approximately 24 months
Secondary outcome [8] 0 0
Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Progression Free Survival (PFS)
Timepoint [8] 0 0
Approximately 24 months

Eligibility
Key inclusion criteria
Key

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 (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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Last administration of prior antitumor therapy:

* Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.
* Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (<2 weeks of radiotherapy) to non-CNS disease.
* Radiation therapy to the lung that is > 30Gy within 6 months prior to start of treatment.
* Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.
2. Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.
3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.
4. Condition requiring long-term systemic treatment with either corticosteroids > 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.
5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.
6. Severe pulmonary, cardiac or other systemic disease.
7. Known hepatitis B or C virus infection.
8. Females who are pregnant or lactating or planning to become pregnant during the study.
9. Has had an allogeneic tissue/solid organ transplant.
10. Active infection requiring systemic therapy.
11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol
12. 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.
13. Known severe hypersensitivity to any component of study drug(s).
14. Inability to comply with study and follow up procedures as judged by the Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
115
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
Macquarie University - Sydney
Recruitment hospital [3] 0 0
Gallipoli Medical Research Foundation - Greenslopes
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2109 - Sydney
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Gangnam-gu
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Gyeonggi-do
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Jongno-gu

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medicenna Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nina Merchant
Address 0 0
Medicenna Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nina Merchant
Address 0 0
Country 0 0
Phone 0 0
604-340-3081
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05086692