RECRUITING

A Beta-only IL-2 ImmunoTherapY Study

Conditions

Advanced Solid Tumor Unresectable Solid Tumor Clear Cell Renal Cell Carcinoma Triple Negative Breast Cancer Non-Small Cell Lung Cancer Squamous Non-Small Cell Lung Cancer Non-squamous Colorectal Cancer (MSI-H)Gastric Cancer Cervical Cancer Basal Cell Carcinoma Bladder Cancer Merkel Cell Carcinoma Squamous Cell Carcinoma of Head and Neck Cutaneous Squamous Cell Carcinoma Pleural Mesothelioma Esophageal Cancer Endometrial Carcinoma Solid Tumor Solid Tumor, Adult MSI-H Solid Malignant Tumor Cancer With A High Tumor Mutational Burden Epithelial Ovarian Carcinoma Primary Peritoneal Cancer Gastroesophageal Junction (GEJ) Cancer Acral Melanoma Mucosal Melanoma Cutaneous Melanoma DMMR Solid Malignant Tumor Fallopian Tube Cancer Ovarian Cancer MSI-H Cancer DMMR Cancer Pancreas Adenocarcinoma (MSI-H)Skin Cancer IL-2 IL2 Interleukin-2 cancer metastatic ccRCC TNBC NSCLC CRC GEJ intrahepatic extrahepatic MCC SCCHN CSCC Gastroesophageal Junction advanced unresectable MSI-H dMMR Microsatellite Instability-High Mismatch Repair Deficient PD-1 immunotherapy anti-PD-1 BCC RCC HCC Tumor Mutation Burden High TMB-H PDAC

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-08-27

Study Completion:2026-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05086692

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 (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.	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.

Inclusion Criteria

Exclusion 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 (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.

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.

Contacts and Locations

Study Contact

Nina Merchant

CONTACT

604-340-3081

nmerchant@medicenna.com

Melissa Coello

CONTACT

267-476-2313

mcoello@medicenna.com

Principal Investigator

Nina Merchant

STUDY_DIRECTOR

Medicenna Therapeutics

Martin Bexon, MBBS

STUDY_CHAIR

Medicenna Therapeutics

Study Locations (Sites)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158

United States

Providence Saint John's Health Center

Santa Monica, California, 90404

United States

Boca Raton Regional Hospital

Boca Raton, Florida, 33486

United States

Orlando Health Cancer Institute

Orlando, Florida, 32806

United States

Emory - Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Medicenna Therapeutics, Inc.

Nina Merchant, STUDY_DIRECTOR, Medicenna Therapeutics
Martin Bexon, MBBS, STUDY_CHAIR, Medicenna Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-27

Study Completion Date2026-12-30

Study Record Updates

Study Start Date2021-08-27

Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

IL-2
IL2
Interleukin-2
cancer
metastatic
ccRCC
TNBC
NSCLC
CRC
GEJ
intrahepatic
extrahepatic
MCC
SCCHN
CSCC
Gastroesophageal Junction
advanced
unresectable
MSI-H
dMMR
Microsatellite Instability-High
Mismatch Repair Deficient
PD-1
immunotherapy
anti-PD-1
BCC
RCC
HCC
Tumor Mutation Burden High
TMB-H
PDAC

Additional Relevant MeSH Terms

Advanced Solid Tumor
Unresectable Solid Tumor
Clear Cell Renal Cell Carcinoma
Triple Negative Breast Cancer
Non-Small Cell Lung Cancer Squamous
Non-Small Cell Lung Cancer Non-squamous
Colorectal Cancer (MSI-H)
Gastric Cancer
Cervical Cancer
Basal Cell Carcinoma
Bladder Cancer
Merkel Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Cutaneous Squamous Cell Carcinoma
Pleural Mesothelioma
Esophageal Cancer
Endometrial Carcinoma
Solid Tumor
Solid Tumor, Adult
MSI-H Solid Malignant Tumor
Cancer With A High Tumor Mutational Burden
Epithelial Ovarian Carcinoma
Primary Peritoneal Cancer
Gastroesophageal Junction (GEJ) Cancer
Acral Melanoma
Mucosal Melanoma
Cutaneous Melanoma
DMMR Solid Malignant Tumor
Fallopian Tube Cancer
Ovarian Cancer
MSI-H Cancer
DMMR Cancer
Pancreas Adenocarcinoma (MSI-H)
Skin Cancer