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Back|NCT05086692Recruiting
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

Phase
Phase 1/Phase 2
Sponsor
Medicenna Therapeutics, Inc.
Enrollment
115
Timeline
Aug 2021 → Dec 2026
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Aged at least 18 years (inclusive at the time of informed consent).
  • 2Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • 3Must 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.
  • 4Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
  • 5Demonstrated adequate organ function
  • 6Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.
  • 7Life expectancy of ≥ 12 weeks.
  • 8Women 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.
  • 9Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.

Exclusion Criteria

  • 1Last administration of prior antitumor therapy:
  • 2Prior 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.
  • 3Prior 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.
  • 4Radiation therapy to the lung that is \> 30Gy within 6 months prior to start of treatment.
  • 5Currently 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.
  • 6Has 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.
  • 7Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.
  • 8Condition 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.
  • 9Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.
  • 10Severe pulmonary, cardiac or other systemic disease.
  • 11Known hepatitis B or C virus infection.
  • 12Females who are pregnant or lactating or planning to become pregnant during the study.
  • 13Has had an allogeneic tissue/solid organ transplant.
  • 14Active infection requiring systemic therapy.
  • 15Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol
  • 16Any 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.
  • 17Known severe hypersensitivity to any component of study drug(s).
  • 18Inability to comply with study and follow up procedures as judged by the Investigator.

Locations

27 sites participating in this study

Emory - Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Sharp Memorial Hospital

San Diego, California 92123

Recruiting

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California 94158

Active, Not Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →