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Clinical Trials in the USA / NCT07887971
Recruiting Phase 1

A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors

NCT07887971 · tracked via the Priya Life Science USA tracker
Sponsor
Aktis Oncology, Inc
Phase
Phase 1
Started
2026-11
Last updated
2026-10-22

Condition(s) studied

NSCLCNSCLC (Advanced Non-small Cell Lung Cancer)ES-SCLCSmall Cell Lung Cancer Extensive StageB7H3Prostate CancerHNSCCmCRPC (Metastatic Castration-resistant Prostate Cancer)Head Neck Cancer Squamous Cell MetastaticESCC or Esophageal Adenosquamous CarcinomaCRCCRC (Colorectal Cancer)

Investigational drug(s) / intervention(s)

[225Ac]Ac-AKY-2519 (therapeutic)[64Cu]Cu-AKY-2519 (imaging)

[225Ac]Ac-AKY-2519 (therapeutic): \[225Ac\]Ac-AKY-2519 Injection

[64Cu]Cu-AKY-2519 (imaging): \[64Cu\]Cu-AKY-2519 Injection

Study summary

This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with B7-H3 imaging positive solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Histologic or cytologic confirmation of locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma * Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1 * ECOG Performance Status of 0 or 1 * Adequate end-organ function * Ability to give informed consent and comply with study requirements * Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids Exclusion Criteria: * Prior treatment with a B7-H3 targeted therapy * Prior treatment with a targeted radiotherapy * Received an investigational agent within the previous 28 days * Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy within the previous 28 days * Impaired cardiac function or clinically significant cardiac disease * Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

Primary outcome measure(s)

  • Part 1: Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519 — Up to 30 days following last administration of [225Ac]Ac-AKY-2519
    An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE and the number of patients experiencing an SAE will be reported.
  • Part 1: Occurrence of dose-limiting toxicity (DLT) in participants — From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days)
    Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT will be reported separately for each cohort and by dose level within each cohort
  • Part 2: Objective Response Rate (ORR) — Up to 30 days following last administration of [225Ac]Ac-AKY-2519
    Part 2: Objective Response Rate (ORR) • Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST v1.1. Up to 30 days following last administration of \[225Ac\]Ac-AKY-2519

Trial sites (1)

FacilityCityRegionStatus
Biogenix Molecular, LLC Miami Florida Recruiting

More Aktis Oncology, Inc. trials in the USA

A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors Recruiting
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer Recruiting

Other trials for the same condition

Study of Oral MRT-2359 in Selected Cancer Patients Active, not recruiting
Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer Active, not recruiting
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors Active, not recruiting
A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects With Select Advanced Solid Tumors Recruiting
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07887971 on ClinicalTrials.gov ↗ ← All trials in the USA