RecruitingPhase 1/2

A Beta-only IL-2 ImmunoTherapY Study

United States115 participantsStarted 2021-08-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Exclusion criteria

✕. Last administration of prior antitumor therapy:
✕. 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.

What they're measuring

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

Timeframe: 24 months

Incidence of Treatment Related Adverse Events (TRAEs)

Timeframe: 24 months

Incidence of Treatment Emergent Adverse Events (TEAEs)

Timeframe: 24 months

Trial details

NCT IDNCT05086692

SponsorMedicenna Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Nina Merchant

604-340-3081 nmerchant@medicenna.com

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Exclusion criteria

✕. Last administration of prior antitumor therapy:
✕. 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.