Clinical Trial: NCT06639191
[177Lu]Lu-AKIR001 First-in-human Study
Status:
RECRUITINGPhase:
Early Phase 1| Lead Sponsor: | Karolinska University Hospital |
| Information Provided By: | Karolinska University Hospital |
| Last Update Posted: | 2026-01-30 |
Study Overview
Brief Summary
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.
Official Title
Conditions
Intervention / Treatment
- Drug: [177Lu]Lu-AKIR001
Other Study ID Numbers
- AKIR001
- 2023-508126-95-00
- 2023
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | Karolinska University Hospital |
| Information Provided By: | Karolinska University Hospital |
| Last Update Posted: | 2026-01-30 |
Study Overview
Brief Summary
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.
Official Title
Conditions
Intervention / Treatment
- Drug: [177Lu]Lu-AKIR001
Other Study ID Numbers
- AKIR001
- 2023-508126-95-00
- 2023