Trial · NCT07887971
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
NCT07887971, Phase 1, Recruiting, Aktis Oncology, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors. Trials, record NCT07887971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07887971
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
- NCT number
- NCT07887971
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 152 participants, estimated
- Lead sponsor
- Aktis Oncology, Inc.
- Conditions
NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer), ES-SCLC, Small Cell Lung Cancer Extensive Stage, B7H3, Prostate Cancer, HNSCC, mCRPC (Metastatic Castration-resistant Prostate Cancer), Head Neck Cancer Squamous Cell Metastatic, ESCC or Esophageal Adenosquamous Carcinoma, CRC, CRC (Colorectal Cancer)
- Interventions
- [225Ac]Ac-AKY-2519 (therapeutic), [64Cu]Cu-AKY-2519 (imaging)
- First posted
- 2026-10-22
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 |
| Primary | 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 |
| Secondary | Part 1: Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu AKY 2519 | Up to 6 days following last administration of [64Cu]Cu AKY 2519 or, if earlier, until the first dose 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 will be reported. |
| Secondary | Part 1: Objective Response Rate (ORR) | Up to 30 days following last administration of [225Ac]Ac-AKY-2519 | ORR 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 or PCWG3-modified RECIST v1.1. |
| Secondary | Part 2: Duration of Response (DoR) | Up to 5 years after first administration | Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. |
| Secondary | Part 2: Progression-Free Survival (PFS) | Up to 5 years after first administration | PFS is defined as the time from treatment initiation to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. |
| Secondary | Part 2: Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu AKY 2519 | Up to 6 days following last administration of [64Cu]Cu AKY 2519 or, if earlier, until the first dose 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 will be reported. |
| Secondary | Part 2: 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07887971
GET https://conductscience.org/api/trials/v1/NCT07887971/registered