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A Beta-only IL-2 ImmunoTherapY Study

NCT05086692 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-07-09

No results posted yet for this study

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

Interventions

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).

DRUG

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).

Sponsors & Collaborators

Principal Investigators

  • Nina Merchant · Medicenna Therapeutics

  • Arash Yavari, MBBS · Medicenna Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2026-06-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Ireland
  • Portugal
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05086692 on ClinicalTrials.gov