A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Recruiting
Phase 1
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Aktis Oncology, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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…
Contacts