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NCT07226986 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 123
- Enrollment target
NCT07226986 is a Phase 1 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 123 participants.
The verdict
NCT07226986, a Phase 1 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 123 participants
- Enrollment target
Study Summary
The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in participants with mCRPC who have failed one prior ARPI, but who have not yet been exposed to taxane treatment.
Interventions
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG AMO959
- RADIATION AAA617
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2025-12-05 |
| Est. Completion | 2029-09-13 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07226986
The ClinicalTrials.gov registry entry for NCT07226986 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Enzalutamide is the first listed.
NCT07226986 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07226986 about?
NCT07226986 is a clinical study titled "A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC". The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an ...
What is the current status of trial NCT07226986?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 123 participants. The study started on 2025-12-05. Estimated completion is 2029-09-13.
What interventions are being tested in trial NCT07226986?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), AMO959 (DRUG), AAA617 (RADIATION).
Who is sponsoring clinical trial NCT07226986?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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