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[177Lu]Lu-AKIR001 First-in-human Study

Study acronym: AKIR001
StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2024 to Jan 28, 2026
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
The goal of this clinical trial is to evaluate the safety and tolerability of increasing doses of \[177Lu\]Lu-AKIR001, both in relation to tolerable activity of lutetium-177 and the absorbed protein mass dose of AKIR-001 in patients with irresectable or metastatic CD44v6-expressing solid malignancies for whom no reasonable systemic treatment options are be available. The main question it aims to answer is: • What is the toxicity profile of the study drug \[177Lu\]Lu-AKIR001 according to the rate of Dose Limiting Toxicities and (Severe) Adverse Events? Participants will receive one \[177Lu\]Lu-AKIR001 infusion followed by a 6-week safety follow-up period, which can be extended up to 12 weeks. Possible additional infusions of the trial drug, up to a maximum number of four, can be given when clinical benefit is noted and toxicity is deemed acceptable.
Trial Details
NCT Number NCT06639191
Lead Sponsor Karolinska University Hospital
Collaborators: Karolinska Institutet, Uppsala University
Conditions
(from sponsor)		 Thyroid Gland Anaplastic Carcinoma, Poorly Differentiated Thyroid Carcinoma, Cancer Head and Neck, Cervix Carcinoma, Vulvar Cancer, Stage IV, Non-small Cell Lung Cancer Stage IV
Related terms Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Thyroid Carcinoma, Anaplastic, Uterine Cervical Neoplasms, Vulvar Neoplasms
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov