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Clinical Trial NCT07020117 for Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adenocarcinoma, Colorectal Adenocarcinoma, Head and Neck Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors Phase 1 150 First-in-Human Open-Label
Clinical Trial NCT07020117 is designed to study Treatment for Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adenocarcinoma, Colorectal Adenocarcinoma, Head and Neck Cancer. It is a Phase 1 interventional study that is recruiting, having started on 22 August 2025, with plans to enroll 150 participants. Led by Aktis Oncology, Inc., it is expected to complete by 1 June 2032. The latest data from ClinicalTrials.gov was last updated on 4 March 2026.
Brief 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.
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 porti...
Show MoreOfficial 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
Conditions
Urothelial Carcinoma BladderTriple Negative Breast Cancer (TNBC)Hormone Receptor Positive Breast AdenocarcinomaNon Small Cell Lung CancerCervical AdenocarcinomaColorectal AdenocarcinomaHead and Neck CancerOther Study IDs
- AKY-1189-01
NCT ID Number
Start Date (Actual)
2025-08-22
Last Update Posted
2026-03-04
Completion Date (Estimated)
2032-06
Enrollment (Estimated)
150
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimental[225Ac]Ac-AKY-1189 | [225Ac]Ac-AKY-1189 (therapeutic) \[225Ac\]Ac-AKY-1189 Injection [64Cu]Cu-AKY-1189 (imaging) \[64Cu\]Cu-AKY-1189 Injection |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | Up to 30 days following last administration |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 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. | Up to 5 years after first administration |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Aktis Oncology, Inc.Study Central Contact
Contact: Janet Horton, MD, 978-208-3986, [email protected]
9 Study Locations in 1 Countries
California
City of Hope, Duarte, California, 91010, United States
Abhishek Tripathi, MD, Contact, 626-256-4673, [email protected]
Recruiting
Hoag Memorial Hospital Presbyterian, Irvine, California, 92618, United States
Ryan Reddy, MD, Contact, 949-764-4577, [email protected]
Recruiting
Florida
Biogenix Molecular, LLC, Miami, Florida, 33165, United States
Jerry Joseph, Contact, (786)791-1799, [email protected]
Recruiting
Iowa
University of Iowa, Iowa City, Iowa, 52242, United States
Kristin West, Contact, 319-356-3656, [email protected]
Kristin Plichta, MD, PhD, Contact
Recruiting
Maryland
United Theranostics, Glen Burnie, Maryland, 21061, United States
Amanda Huggins, Contact, 667-HOPENOW, [email protected]
Recruiting
Michigan
BAMF Health, Grand Rapids, Michigan, 49503, United States
Contact, 616-330-2735, [email protected]
Recruiting
New York
Icahn School of Medicine at Mt. Sinai, New York, New York, 10029, United States
Sophia Rhoads, Contact, 317-903-4419, [email protected]
Patricia Acon, Contact, [email protected]
Recruiting
Pennsylvania
UPMC, Pittsburgh, Pennsylvania, 15232, United States
Samantha Demko, RN, BSN, Contact, 412-623-1400, [email protected]
Recruiting
Texas
MD Anderson Cancer Center, Houston, Texas, 77030, United States
Natalie Velez, Contact, 713-792-1478, [email protected]
Recruiting