A Beta-only IL-2 ImmunoTherapY Study

Part of paid clinical trials in San Diego, California.

Sponsor
Medicenna Therapeutics, Inc.
Study ID
NCT05086692
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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).

Study Details

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.

Key Dates

Start date
Aug 27, 2021
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
115 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE) [ Time Frame: 24 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Sharp Memorial HospitalSan DiegoCalifornia92123-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
Providence Saint John's Health CenterSanta MonicaCalifornia90404-
Boca Raton Regional HospitalBoca RatonFlorida33486-
Emory - Winship Cancer InstituteAtlantaGeorgia30322-
Karmanos Cancer InstituteDetroitMichigan48201-
MD Anderson Cancer CenterHoustonTexas77030-

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Sharp Memorial Hospital· San Diego, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAProvidence Saint John's Health Center· Santa Monica, CABoca Raton Regional Hospital· Boca Raton, FLEmory - Winship Cancer Institute· Atlanta, GAKarmanos Cancer Institute· Detroit, MI

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