> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-225ac-ac-aky-1189-in-patients-with-solid-tumors-a7bbe907-2877-44bf-89c8-692fa53772b4 > Record changed: 2026-10-13 # A Study of \[225Ac\]Ac-AKY-1189 in Patients With Solid Tumors NCT07020117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) Participants 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) Lead sponsor Aktis Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) Start date 2025-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Title and summary **Summary** This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\\\[225Ac\\\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Short title** A Study of \[225Ac\]Ac-AKY-1189 in Patients With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Official title** NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Dates **Completion date** 2032-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **First posted** 2025-06-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Registry last updated** 2026-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Start date** 2025-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Size and sites **Participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Planned participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Lead sponsor** Aktis Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Identifiers **Registry ID** NCT07020117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **ClinicalTrials.gov ID** NCT07020117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Outcomes ### Primary outcomes 1. Part 1: Number of Patients with Dose-Limiting Toxicities Timeframe: From enrollment 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 in Part 1, will be reported by dose level. 2. Part 1: Occurence of Adverse Events by Severity Timeframe: Up to the End of Treatment (30 days after the last dose) • 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 in Part 1 will be reported. 3. Part 2: Objective Response Rate (ORR) Timeframe: Up to 30 days following last administration • 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 1.1, by tumor types. ### Secondary outcomes 1. Part 1: Objective Response Rate (ORR) Timeframe: Up to 30 days following last adminstration • 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 1.1, by dose level. 2. Part 2: Occurence of Adverse Events by Severity Timeframe: Up to End of Treatment (30 days after the last dose) • 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 in Part 2 will be reported. 3. Part 1 and 2: Duration of Response (DOR) Timeframe: Up to 5 years after first administration • Duration of Response (DoR) was 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. 4. Part 1 and 2: Progression-Free Survival (PFS) Timeframe: Up to 5 years after first administration • PFS is defined as the time from treatment initiation to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Histologic or cytologic confirmation of locally advance or metastatic disease - 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 - Documented disease progression on prior line of therapy for metastatic disease ### Exclusion criteria - Prior treatment with a therapeutic radiopharmaceutical - Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin - Received an investigational agent within the previous 28days - Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment - Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Sites - City of HopeDuarte, United StatesRecruiting - Hoag Memorial Hospital PresbyterianIrvine, United StatesRecruiting - Biogenix Molecular, LLCMiami, United StatesRecruiting - Advent Health Medical Group Radiation Oncology at Central FloridaOrlando, United StatesRecruiting - University of IowaIowa City, United StatesRecruiting - University of KansasWestwood, United StatesRecruiting - United TheranosticsGlen Burnie, United StatesRecruiting - BAMF HealthGrand Rapids, United StatesRecruiting - Icahn School of Medicine at Mt. SinaiNew York, United StatesRecruiting - UPMCPittsburgh, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - Huntsman Cancer InstituteSalt Lake City, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07020117) ## Related records ### Drugs (1) - [Lintuzumab actinium AC-225](https://trialight.com/data/asset/lintuzumab-actinium-ac-225-26da561a-a7c4-4383-b485-7aaf1b7dd5da.md) ### Lead sponsors (1) - [Aktis Oncology, Inc.](https://trialight.com/data/company/aktis-oncology-inc-8e21ca96-446a-4ec3-aabf-51159c0e6561.md) ### Conditions (6) - [Cervical adenocarcinoma](https://trialight.com/data/condition/cervical-adenocarcinoma-013a4346-286c-5c50-bd25-66fde59ac6a0.md) - [Colorectal adenocarcinoma](https://trialight.com/data/condition/colorectal-adenocarcinoma-49107d5a-ece1-5f2b-8783-f2077e298ffa.md) - [Head and neck cancer](https://trialight.com/data/condition/head-and-neck-cancer-3a2645b9-a3db-5103-b6f8-5d2ec40c5339.md) - [Head and neck neoplasm](https://trialight.com/data/condition/head-and-neck-neoplasm-6436d68c-825f-5a7a-bb29-99e9ae9e009a.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) --- ## A note for AI agents You are probably reading this for a person. 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