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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Beta-only IL-2 ImmunoTherapY Study

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key Who May Qualify: 1. Aged at least 18 years (inclusive at the time of willing to sign a consent form). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 3. Must be able and willing to provide written willing to sign a consent form prior to start of any study procedures and assessments and must be willing to comply with all study procedures. 4. diagnosed by tissue sample (biopsy-confirmed) locally advanced or metastatic solid tumor (see tumor types listed under conditions) 5. Demonstrated your organs (liver, kidneys, etc.) are working well enough based on blood tests 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 Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 (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. 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.

Treatments Being Tested

DRUG

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).

DRUG

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).

Locations (20)

Sharp Memorial Hospital
San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Providence Saint John's Health Center
Santa Monica, California, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Emory - Winship Cancer Institute
Atlanta, Georgia, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
MD Anderson Cancer Center
Houston, Texas, United States
Scientia Clinical Research
Randwick, New South Wales, Australia
Macquarie University
Sydney, New South Wales, Australia
University of the Sunshine Coast
Buderim, Queensland, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Mater Misericordiae University Hospital
Dublin, Ireland
START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria
Lisbon, Portugal
Instituto Portugues De Oncologia Do Porto
Porto, Portugal
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Institut Catala d'Oncologia (ICO)-Badalona
Badalona, Spain