Urothelial Carcinoma BladderPhase 1NCT07020117
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
A Phase 1 study testing [225Ac]Ac-AKY-1189 (therapeutic) and [64Cu]Cu-AKY-1189 (imaging) in people with Urothelial Carcinoma Bladder and Triple Negative Breast Cancer (TNBC), run by Aktis Oncology, Inc. at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma
- What is being tested?
- [225Ac]Ac-AKY-1189 (therapeutic) and [64Cu]Cu-AKY-1189 (imaging)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 14 sitesUnited States
- Study dates
- 22 Aug 2025to Jun 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Abhishek Tripathi, MD, 626-256-4673, atripathi@coh.org
- Recruiting
United Theranostics
Glen Burnie, Maryland, 21061
Amanda Huggins, 667-467-3669, clinicaltrial@unithera.com
- Recruiting
BAMF Health
Grand Rapids, Michigan, 49503
616-330-2735, ResearchClinicalTeam@bamfhealth.com
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Natalie Velez, 713-792-1478, navelez@mdanderson.org
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Kristin West, 319-356-3656, kristin-gaimari-varner@uiowa.edu
Kristin Plichta, MD, PhD
- Recruiting
Hoag Memorial Hospital Presbyterian
Irvine, California, 92618
Ryan Reddy, MD, 949-764-4577, ryan.reddy@hoag.org
- Recruiting
Biogenix Molecular, LLC
Miami, Florida, 33165
Jerry Joseph, (786)791-1799, jjoseph@cira-health.com
- Recruiting
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Sophia Rhoads, 317-903-4419, Sophia.rhoads@mssm.edu
Patricia Acon, patricia.acon@mssm.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Somali Gavane, MD, 212-639-2403, GavaneS@mskcc.org
- Recruiting
Advent Health Medical Group Radiation Oncology at Central Florida
Orlando, Florida, 32804
Bridget Koontz, MD, 407-303-2024, Bridget.koontz.MD@adventhealth.com
- Recruiting
UPMC
Pittsburgh, Pennsylvania, 15232
Samantha Demko, RN, BSN, 412-623-1400, albesl@upmc.edu
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Sklyler Johnson, 801-585-0255, Skyler.johnson@hci.utah.edu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Rachel Erickson, (813)745-2737, Rachel.Erickson@moffitt.org
- Recruiting
University of Kansas
Westwood, Kansas, 66205
KUCC Nurse Navigation, 913-945-7552, CTNurseNav@kumc.edu
About this study
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
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.
Read the detailed description
This study consists of two parts (Part 1 and 2).
Part 1 is the dose escalation portion of the study, which will investigate ascending doses of [225Ac]Ac-AKY-1189 (up to 6 cycles) in patients with locally advanced or metastatic solid tumors. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.
Part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as Nectin-4 positive by [64Cu] Cu-AKY-1189. Part 2 aims to further assess the efficacy of [225Ac]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.
- Conditions
- Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adenocarcinoma, Colorectal Adenocarcinoma
- Being tested
- [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
- Medical subject headings
- Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[225Ac]Ac-AKY-1189 (therapeutic)Drug
[225Ac]Ac-AKY-1189 Injection
[64Cu]Cu-AKY-1189 (imaging)Drug
[64Cu]Cu-AKY-1189 Injection
| Study group | Role | What they receive |
|---|---|---|
| [225Ac]Ac-AKY-1189 | Experimental | Not described Receives: Drug: [225Ac]Ac-AKY-1189 (therapeutic); Drug: [64Cu]Cu-AKY-1189 (imaging) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Patients with Dose-Limiting Toxicities
- 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.
Measured: From enrollment to the end of Cycle 1 (each cycle is 28 days)
Part 1: Occurence of Adverse Events by Severity
- 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.
Measured: Up to the End of Treatment (30 days after the last dose)
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 1.1, by tumor types.
Measured: Up to 30 days following last administration
Secondary outcomes (4)
Part 1: 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 1.1, by dose level.
Measured: Up to 30 days following last adminstration
Part 2: Occurence of Adverse Events by Severity
- 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.
Measured: Up to End of Treatment (30 days after the last dose)
Part 1 and 2: Duration of Response (DOR)
- 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.
Measured: Up to 5 years after first administration
Part 1 and 2: Progression-Free Survival (PFS)
- 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.
Measured: Up to 5 years after first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start22 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aktis Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020117
- Sponsor's protocol ID
- AKY-1189-01
- Status last verified
- Nov 2025
- First submitted
- 28 May 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07020117
- Acronym / sponsor ID
- AKY-1189-01
- Conditions
- Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adenocarcinoma, Colorectal Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aktis Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of two parts (Part 1 and 2).
Part 1 is the dose escalation portion of the study, which will investigate ascending doses of [225Ac]Ac-AKY-1189 (up to 6 cycles) in patients with locally advanced or metastatic solid tumors. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.
Part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as Nectin-4 positive by [64Cu] Cu-AKY-1189. Part 2 aims to further assess the efficacy of [225Ac]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [225Ac]Ac-AKY-1189 | Experimental | Drug: [225Ac]Ac-AKY-1189 (therapeutic), Drug: [64Cu]Cu-AKY-1189 (imaging) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [225Ac]Ac-AKY-1189 (therapeutic)[225Ac]Ac-AKY-1189 Injection | Drug | [225Ac]Ac-AKY-1189 |
| [64Cu]Cu-AKY-1189 (imaging)[64Cu]Cu-AKY-1189 Injection | Drug | [225Ac]Ac-AKY-1189 |
Primary outcome
Part 1: Number of Patients with Dose-Limiting Toxicities
Time frame: 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.
Part 1: Occurence of Adverse Events by Severity
Time frame: 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.
Part 2: Objective Response Rate (ORR)
Time frame: 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.
4 secondary outcomes
Part 1: Objective Response Rate (ORR)
Time frame: Up to 30 days following last adminstration
Part 2: Occurence of Adverse Events by Severity
Time frame: Up to End of Treatment (30 days after the last dose)
Part 1 and 2: Duration of Response (DOR)
Time frame: Up to 5 years after first administration
Part 1 and 2: Progression-Free Survival (PFS)
Time frame: Up to 5 years after first administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [225Ac]Ac-AKY-1189 (therapeutic) and [64Cu]Cu-AKY-1189 (imaging) in people with Urothelial Carcinoma Bladder and Triple Negative Breast Cancer (TNBC), run by Aktis Oncology, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Horton, MD (978-208-3986, AKY-1189-01inquiries@aktisoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Patients with Dose-Limiting Toxicities (time frame: From enrollment to the end of Cycle 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.