[177Lu]Lu-AKIR001 First-in-human Study (NCT06639191) | Clinical Trial Compass
RecruitingEarly Phase 1
[177Lu]Lu-AKIR001 First-in-human Study
Sweden15 participantsStarted 2026-01-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participant must be 18 years of age or older
✓. Willing and able to provide written informed consent
✓. Participant has one of the following histologically confirmed metastatic or locally advanced irresectable CD44v6 expressing (confirmed in pre-screening according to the pathology manual (Appendix III) solid malignancy in one of the following groups, with documented disease progression in the last 8 weeks during/after available standard of care treatment options as mentioned below:
✓. Measurable disease per Response Criteria for Solid Tumours (RECIST) v1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
✓. Life expectancy of at least three months as estimated by the investigator.
✓. Adequate organ and bone marrow function within eight days before the first \[177Lu\]Lu-AKIR001 infusion:
✓. Contraceptives
Exclusion criteria
✕
What they're measuring
1
Primary Endpoint - rate of dose limiting toxicities
Timeframe: From first dose to a minimum of 6 weeks post-dose.
. Symptomatic brain metastases that are not previously treated and/or that require ongoing steroid-treatment
✕. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
✕. Chemo-, targeted or radiotherapy within the last 4 weeks before enrolment in the study.
✕. Ongoing toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) \> 1 from previous anti-cancer treatments.
✕. Pregnancy or lactation
✕. Uncontrolled hypertension, heart, liver, or kidney disease or other medical/ psychiatric disorders.
✕. Severe skin diseases requiring systemic anti-inflammatory treatment, including plaque psoriasis, Stevens Johnsons syndrome or dermatomyositis.
✕. A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.