A Beta-only IL-2 ImmunoTherapY Study

Study acronym: ABILITY-1
StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 30, 2026 → Nov 30, 2026
See other at-risk trials from Medicenna Therapeutics, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 30, 2026 to Nov 30, 2026 Show 7 more changesShow less
    • Enrollment increased: 115 → 160 participants
    • Study completion pushed from Dec 30, 2026 to Dec 30, 2028
    • Study sites: 27 to 28
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 4 of 8 entries
    • Collaborators: details revised at 1 of 1 entry
    • Study description expanded, about 4 words
  2. Study sites: 24 to 27v24
  3. Study sites: 15 to 24v23
  4. Study sites: 16 to 15v22
  5. Interventions: MDNA11 (Drug), Pembrolizumab (Drug) to MDNA11 (Drug), Pembrolizumab (KEYTRUDA®) (Drug)v21
Show 19 earlier versionsHide 19 earlier versions
  1. Site details revised at 1 of 16 sitesv20
  2. Primary completion date: Sep 30, 2024 to Jun 30, 2026v19 Show 5 more changesShow less
    • Primary endpoints revised (3)
    • Study sites: 10 to 16
    • Eligibility criteria revised
    • Secondary endpoints: 7 to 8
    • Study description shortened, about 6 words
  3. Study sites: 8 to 10v18
  4. Study sites: 7 to 8
    • Interventions: Combination (MDNA11 + pembrolizumab) (Drug), MDNA11 Monotherapy (Drug) to MDNA11 (Drug), Pembrolizumab (Drug)
    • Collaborators expanded, about 5 words
    v17
  5. Primary endpoints revised (3)v16 Show 8 more changesShow less
    • Enrollment target: 100 to 115
    • Study sites: 8 to 7
    • Study completion date: Dec 30, 2024 to Dec 30, 2026
    • Interventions: MDNA11 Monotherapy (Drug), MDNA11 in combination with checkpoint inhibitor (Drug) to Combination (MDNA11 + pembrolizumab) (Drug), MDNA11 Monotherapy (Drug)
    • Eligibility criteria expanded, about 169 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Study description expanded, about 53 words
    • Study title shortened, about 1 word
  6. Study sites revised (8)v15
  7. Study sites revised (8)v14
  8. Enrollment target: 80 to 100
    • Study sites: 9 to 8
    • Eligibility criteria expanded, about 35 words
    • Study description expanded, about 1 word
    v13
  9. Site details revised at 1 of 9 sitesv12
  10. Site details revised at 1 of 9 sitesv11
  11. Site details revised at 1 of 9 sitesv10
  12. Study sites: 6 to 9
    • Secondary endpoints: 8 to 7
    v9
  13. Re-verified, no change to tracked fieldsv8
  14. Study sites: 5 to 6v7
  15. Site details revised at 1 of 5 sitesv6
  16. Site details revised at 1 of 5 sitesv5
  17. Site details revised at 1 of 5 sitesv4
  18. Re-verified, no change to tracked fieldsv3
  19. Study sites: 2 to 5v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Medicenna Therapeutics, Inc.
1 trial monitored
See 1 trial at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Colorectal Cancer
3,405 trials monitored
See 162 trials at risk
and 13 more diseases
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.
Trial Details
NCT Number NCT05086692
Lead Sponsor Medicenna Therapeutics, Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Advanced Solid Tumor, Unresectable Solid Tumor, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer, Non-Small Cell Lung Cancer Squamous, Non-Small Cell Lung Cancer Non-squamous, Colorectal Cancer (MSI-H), Gastric Cancer +29 more
Related terms Basal Cell Carcinoma, Carcinoma, Merkel Cell, Carcinoma, Ovarian Epithelial, Carcinoma, Renal Cell, Colorectal Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Fallopian Tube Neoplasms, Melanoma, Mesothelioma, Malignant, Neoplasm Metastasis, Neoplasms, Ovarian Neoplasms, Skin Neoplasms, Squamous Cell Carcinoma of Head and Neck, Stomach Neoplasms, Triple Negative Breast Neoplasms, Turcot syndrome, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov