Eight patients into a first-in-human trial, and no dose-limiting toxicities have appeared. That number is small, but for a radiopharmaceutical targeting CD44v6-positive solid tumors in patients who have exhausted standard options, it is the detail that will draw attention when Akiram Therapeutics presents at EANM 2026 in Vienna on October 18.
The Phase I data for 177Lu-AKIR001 (NCT06639191), collected at Karolinska University Hospital, show treatment-related adverse events confined to grade 1-2, and four of the eight patients tolerated repeat dosing. Quantitative imaging confirmed that the lutetium-177 payload clears from blood and healthy tissue while staying in tumor, which is the pharmacokinetic behavior the drug’s design is meant to produce. The trial is still escalating doses, so the safety floor has not yet been found, but the early curve is clean.
One finding with real selection implications emerged from the imaging data: low CD44v6 expression measured by immunohistochemistry consistently predicted low absorbed tumor dose. That correlation suggests IHC could screen out patients unlikely to benefit before treatment starts, a practical tool the field needs given how broadly CD44v6 is expressed across solid tumor types. The abstract earned a Top Rated Oral Presentation designation at EANM, as did a second Akiram abstract presenting preclinical work on a derived scFv antibody format of the same platform in bladder cancer, expanding the target tissue list without requiring a new radioisotope or targeting mechanism. The radiopharmaceutical space has grown more competitive with Novartis’s Pluvicto establishing lutetium-177 as a clinical-grade modality in prostate cancer, which means the manufacturing and dosimetry infrastructure AKIR001 would rely on is no longer theoretical.
The concrete marker to track from here is whether the dose-escalation arm surfaces any organ toxicity as activity levels rise. If the grade 1-2 ceiling holds at therapeutic doses, the IHC stratification data becomes a viable patient-selection strategy worth building a Phase II around.
AKIR001: the facts in one place
- Also written: ¹⁷⁷Lu-AKIR001, 177Lu-AKIR001, [177Lu]Lu-AKIR001
- Sponsor: Karolinska University Hospital
- Mechanism: Lutetium-177 conjugated to a proprietary antibody targeting CD44v6, delivering targeted radiation to tumor cells to induce DNA breakage and cell death
- Indication studied: Irresectable or metastatic CD44v6-positive solid tumors, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma, and non-small cell lung cancer
- Phase: Phase I
- Enrollment: 8
- Primary endpoint: Rate of dose-limiting toxicities
- Headline result: As of October 13, 2026, eight patients treated with no dose-limiting toxicities observed; treatment-related adverse events limited to grade 1-2
- Registry identifier: NCT06639191
- Current status: Ongoing first-in-human Phase I dose-escalation trial; progressed to cohort 3 as of May 2026
- Swedish Medical Products Agency approval for Phase 1 initiation: October 22, 2024
- First patient enrolled: April 30, 2025
- Progression to cohort 3: May 13, 2026
- Lutetium-177 supply agreement with ITM signed: August 20, 2026
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
