Recruiting
Phase 1
Phase 2

IL-2 ImmunoTherapy

Sponsor:

Medicenna Therapeutics, Inc.

Code:

NCT05086692

Conditions

Advanced Solid Tumor

Unresectable Solid Tumor

Clear Cell Renal Cell Carcinoma

Triple Negative Breast Cancer

Non-Small Cell Lung Cancer Squamous

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MDNA11

Pembrolizumab (KEYTRUDA®)

Study Details

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

Study ID

NCT05086692

Start date

Aug 27, 2021

Status verified date

Jul, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

115 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MDNA11

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

Interventions

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).

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).

Primary outcome measure

  • MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE) [ Time Frame: 24 months ]
  • Incidence of Treatment Related Adverse Events (TRAEs) [ Time Frame: 24 months ]
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 24 months ]

Central Contacts and Locations

Locations

Sharp Memorial Hospital

Recruiting

San Diego, California, United States, 92123

Providence Saint John's Health Center

Recruiting

Santa Monica, California, United States, 90404

Boca Raton Regional Hospital

Recruiting

Boca Raton, Florida, United States, 33486

Emory - Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M4W 3E2

More Information

Sponsor

Medicenna Therapeutics, Inc.

Last update posted

Jul 9, 2025

Last verified

Jul, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medicenna Therapeutics, Inc. on 2025-07-09.