Save

A Beta-only IL-2 ImmunoTherapY Study

PHASE1PHASE2RECRUITING

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.

Simpliy with AI

Study details:

The study drug, MDNA11, long-acting "beta-only" recombinant interleukin-2 (rIL-2). MDNA11 specifically engineered to overcome the shortcomings of rhIL-2 (aldesleukin) by preferentially activating immune effector cells (CD8+ T- and NK cells) responsible for killing cancer cells, with minimal or no stimulation of 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 up to 30 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 multiple parts:. * Monotherapy (MDNA11 alone) dose escalation.

* Monotherapy (MDNA11 alone) dose expansion in select tumor types. * Combination (MDNA11 + pembrolizumab) dose escalation. * Combination (MDNA11 + pembrolizumab) dose expansion in select tumor types.

Approximately 115 patients will be enrolled. After commencing treatment (first exposure of MDNA11 alone or MDNA11 + pembrolizumab), tumor assessment by CT/MRI will be performed every 8 weeks ± 1 week until immune confirmed progressive disease ("iCPD") by iRECIST, discontinuation of study drug(s), withdrawal of consent or loss to follow-up. Treatment beyond progression may be permitted if criteria are met.

Patients can withdraw from participation at any time.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Exclusion criteria

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.

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.

Known severe hypersensitivity to any component of study drug(s).

Inability to comply with study and follow up procedures as judged by the Investigator.

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-08-27

Primary completion: 2026-06-30

Study completion finish: 2026-12-30

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT05086692

Intervention or treatment

DRUG: MDNA11

DRUG: Pembrolizumab (KEYTRUDA®)

Conditions

• Advanced Solid Tumor
• Gastric Cancer
• Cervical Cancer
• Bladder Cancer
• Esophageal Cancer
• Solid Tumor, Adult
• Ovarian Cancer
• 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)
• Basal Cell Carcinoma
• Merkel Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Cutaneous Squamous Cell Carcinoma
• Pleural Mesothelioma
• Endometrial Carcinoma
• Solid Tumor
• 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
• MSI-H Cancer
• DMMR Cancer
• Pancreas Adenocarcinoma (MSI-H)
• Skin Cancer

Condition: Advanced Solid Tumor, Gastric Cancer and more
DRUG: MDNA11 and other drugs
Randwick, New South Wales, Australia and more
Sponsor: Medicenna Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Scientia Clinical Research

Research sites nearby

Select from list below to view details:

Scientia Clinical Research
Randwick, New South Wales, Australia
Macquarie University
Sydney, New South Wales, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: MDNA11 MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion	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).

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Pharmacokinetic characteristics on MDNA11 - Cmax (ug/mL)	Maximum observed serum drug concentration	Up to 24 months
Pharmacokinetic characteristics on MDNA11 - Tmax (h)	Time to maximum observed serum drug concentration	Up to 24 months
Pharmacokinetic characteristics on MDNA11 - AUClast (h.ug/mL)	Area under the serum concentration vs time curve from time zero to the last measurable concentration	Up to 24 months
Immunogenicity of MDNA11 (anti-drug antibodies)	Incidence and persistence of anti-drug antibodies to MDNA11	Up to 24 months
Pharmacodynamic effects of MDNA11	Measurement of translational parameters - Flow cytometry analysis of immune cells in blood and serum measurements of cytokine levels	Up to 24 months
Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Overall Response Rate (ORR)	Assessed by RECIST v1.1 and iRECIST; CR+PR/Evaluable N	Approximately 24 months
Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Disease Control Rate (DCR)	CR+PR+SD/Evaluable N	Approximately 24 months
Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Progression Free Survival (PFS)	Time from signing ICF to disease progression	Approximately 24 months

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Beta-only IL-2 ImmunoTherapY Study