Aktis targets Q1 2027 dose-finding readout for Nectin-4 radioconjugate AKY-1189
Fast Track-designated AKY-1189 will report Part 1 safety and dose-limiting toxicity data as the only Phase 1 Nectin-4 radioconjugate in a field otherwise led by antibody-drug conjugates.
Executive Summary
- Aktis Oncology has repeated guidance for a Q1 2027 window to report the first Part 1 data on its Nectin-4-targeted radioconjugate, positioning dose-limiting toxicity and adverse-event findings as the near-term test.
- The FDA granted the program Fast Track designation earlier in 2026, a signal of recognized unmet need in previously treated urothelial cancer rather than any read on the eventual outcome.
- The asset stands alone as the only Phase 1 entrant targeting Nectin-4 across this six-tumor-type population, using a radioisotope-delivery mechanism that differs from the antibody-drug conjugates that dominate Nectin-4 development.
- Enrollment and trial status have moved without disruption since the study began recruiting, so execution is not the open issue; what the dose-escalation cohort shows about tolerability is.
The catalyst
Aktis Oncology expects to report preliminary Part 1 data from the Phase 1b trial of AKY-1189 in the first quarter of 2027, according to a March 30, 2026 disclosure that was reiterated in a May 11, 2026 update. The trial, registered as NCT07020117, is testing Ac-AKY-1189 in patients with locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. The company has held the same Q1-2027 window across both disclosures without revision. [DOC-1, 225Ac, NCT07020117]
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The Phase 1b study is designed in two parts: Part 1 measures the number of patients with dose-limiting toxicities and the occurrence of adverse events by severity, while Part 2 measures objective response rate. That structure means the Q1 2027 readout is a safety and dose-finding signal, not an efficacy verdict; a decision to advance into Part 2 will hinge on whether the escalation cohort clears an acceptable toxicity bar. The trial enrolls patients with ECOG performance status of 0 to 1 who have documented disease progression on a prior line of therapy, targeting 150 patients across nine U.S. sites. NCT07020117A Study of [225Ac]Ac-AKY-1189 in Patients With Solid TumorsNCT07020117
Regulatory signal
The FDA granted AKY-1189 Fast Track designation in February 2026 for adult patients with locally advanced or metastatic urothelial cancer who progressed on or after prior systemic therapy. Fast Track designation reflects the FDA's assessment of unmet need in this pretreated population; it carries no bearing on whether the Part 1 dose-escalation data will clear its safety bar. Aktis, which trades as AKTS, priced a January 2026 initial public offering and separately advanced a second miniprotein radioconjugate, AKY-2519, targeting B7-H3, toward its own Phase 1b trial in mid-2026. AktisAktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 ...Mar 30, 2026
The competitive field
AKY-1189 is the only Phase 1 asset targeting Nectin-4 in this six-tumor-type population, while direct comparators sharing the same target, Merck's MK-3120 and Samsung Bioepis's SBE303, are antibody-drug conjugates rather than radioconjugates. Nectin-4 is more broadly targeted by enfortumab vedotin, an approved antibody-drug conjugate now in Phase 3 combination testing in muscle-invasive bladder cancer. Against that backdrop, AKY-1189 tests whether a radioisotope-delivery approach can reach Nectin-4-expressing tumors with a tolerability profile that supports moving beyond dose-finding, a question the antibody-drug conjugate class has already answered for itself through approval.
Trial conduct
The study has shown no material disruption since it opened. It moved from Not yet recruiting to Recruiting in June 2025, and its enrollment target of 150 has held flat with no growth or contraction recorded. The registry has logged one eligibility-criteria adjustment and no changes to the primary completion date, which remains set at December 1, 2027, nine months past the guided data window. NCT07020117A Study of [225Ac]Ac-AKY-1189 in Patients With Solid TumorsNCT07020117
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.