Vulvar Cancer, Stage IV

1

Review clinical trials related to Vulvar Cancer, Stage IV. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 15
Trial details
Phase: Early Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Karolinska University HospitalUpdated: Jan 30, 2026Locations: 1
Eligibility criteria

Participant must be 18 years of age or older [+20]

Symptomatic brain metastases that are not previously treated and/or that require... [+7]