A Beta-only IL-2 ImmunoTherapY Study

NCT05086692 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: MDNA11-01KEYNOTE-E53MK3475-E532023-507536-21-00
• Study Type: interventional
• Target: 115
• Locations: 7 countries
• Sites: 27

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.

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; Viral Cancer; Cervical Cancers; Endometrial Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE)

  Evaluation of tolerability as measured by number of patients with dose limiting toxicities (DLTs)

  24 months

• Incidence of Treatment Related Adverse Events (TRAEs)

  Rate of TRAEs in patients with advanced solid tumors

  24 months

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Rate of TEAEs in patients with advanced solid tumors

  24 months

Secondary Outcomes (8)

• Pharmacokinetic characteristics on MDNA11 - Cmax (ug/mL)

  Up to 24 months

• Pharmacokinetic characteristics on MDNA11 - Tmax (h)

  Up to 24 months

• Pharmacokinetic characteristics on MDNA11 - AUClast (h.ug/mL)

  Up to 24 months

• Immunogenicity of MDNA11 (anti-drug antibodies)

  Up to 24 months

• Pharmacodynamic effects of MDNA11

  Up to 24 months

Other Outcomes (1)

• Analysis of immune characteristics of the tumor microenvironment

  Up to 24 months

Study Arms (1)

MDNA11

EXPERIMENTAL

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

Drug: MDNA11; Drug: Pembrolizumab (KEYTRUDA®)

Interventions

MDNA11 DRUG

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).

Also known as: Interleukin-2 (IL-2)-albumin

MDNA11

Pembrolizumab (KEYTRUDA®) DRUG

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).

MDNA11

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male Female (Women of Childbearing Potential will be subject to pregnancy testing)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged at least 18 years (inclusive at the time of informed consent).
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• 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.
• Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
• Demonstrated adequate organ function
• Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.
• Life expectancy of ≥ 12 weeks.
• 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.
• Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.

You may not qualify if:

• 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.
• 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.
• Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.
• 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.
• Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.
• Severe pulmonary, cardiac or other systemic disease.
• Known hepatitis B or C virus infection.
• Females who are pregnant or lactating or planning to become pregnant during the study.
• Has had an allogeneic tissue/solid organ transplant.
• Active infection requiring systemic therapy.
• Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol

Sponsors & Collaborators

• Medicenna Therapeutics, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (27)

Sharp Memorial Hospital

San Diego, California, 92123, United States

RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, United States

ACTIVE NOT RECRUITING

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

RECRUITING

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

RECRUITING

Emory - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

RECRUITING

Macquarie University

Sydney, New South Wales, 2109, Australia

RECRUITING

University of the Sunshine Coast

Buderim, Queensland, 4556, Australia

RECRUITING

Gallipoli Medical Research Foundation

Greenslopes, Queensland, 4120, Australia

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M4W 3E2, Canada

RECRUITING

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

RECRUITING

START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria

Lisbon, 1649-035, Portugal

RECRUITING

Instituto Portugues De Oncologia Do Porto

Porto, 4200-072, Portugal

RECRUITING

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

ACTIVE NOT RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

ACTIVE NOT RECRUITING

The Catholic University of Korea St. Vincent Hospital

Suwon, Gyeonggi-do, South Korea

ACTIVE NOT RECRUITING

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

ACTIVE NOT RECRUITING

Institut Catala d'Oncologia (ICO)-Badalona

Badalona, 08916, Spain

RECRUITING

START Barcelona / HM Nou Delfos

Barcelona, 08023, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

START Madrid / Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Hm Sanchinarro

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Central de Asturias (HUCA)

Oviedo, 33011, Spain

RECRUITING

Hospital Universitario de Torrejon

Torrejón, 28850, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Triple Negative Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms; Carcinoma, Basal Cell; Urinary Bladder Neoplasms; Carcinoma, Merkel Cell; Squamous Cell Carcinoma of Head and Neck; Mesothelioma, Malignant; Esophageal Neoplasms; Endometrial Neoplasms; Carcinoma, Ovarian Epithelial; Neoplasms; Melanoma; Fallopian Tube Neoplasms; Ovarian Neoplasms; Skin Neoplasms; Neoplasm Metastasis; Turcot syndrome

Interventions

Interleukin-2; pembrolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Neoplasms, Basal Cell; Urinary Bladder Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Mesothelioma; Adenoma; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Nevi and Melanomas; Fallopian Tube Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Nina Merchant

  Medicenna Therapeutics

  STUDY DIRECTOR

• Arash Yavari, MBBS

  Medicenna Therapeutics

  STUDY CHAIR

Central Study Contacts

Nina Merchant

CONTACT

604-340-3081; nmerchant@medicenna.com

Melissa Coello

CONTACT

267-476-2313; mcoello@medicenna.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential dose escalation (MDNA11 monotherapy and MDNA11 + pembrolizumab) followed by dose expansion with MDNA11 monotherapy and combination (MDNA11 + pembrolizumab).

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 21, 2021
• Study Start: August 27, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); AU (4); IE (1); ES (8); CA (1); PT (2); KR (4)