Taking people in ItalyPhase 1/2

Tests AMO959 with radioactive AAA617 in men with advanced prostate cancer

Tests AMO959 with radioactive AAA617 and an ARPI in adults with advanced prostate cancer.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where: Cona, Milan, and Naples, ItalySee the 3 sites
Phase: Phase 1/2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men with metastatic castration-resistant prostate cancer that shows PSMA on a PET scan and that grew after one earlier ARPI.

Age: 18 years or older
Sex: Men only
Disease stage: Metastatic castration-resistant prostate cancer (adenocarcinoma of the prostate), PSMA-PET positive, with testosterone at castration level (< 50 ng/dL) and/or ongoing ADT. Cancer progressed on one ARPI as the last treatment.
Earlier treatment: Must have had one prior ARPI and not more than one. Phase Ib: up to 1 line of taxane chemotherapy is allowed. Phase II: no taxane chemotherapy for mCRPC (allowed earlier, for mHSPC). Cannot have had any RLT or PSMA-targeted treatment.
Biomarker or test result: PSMA-positive disease on a PSMA PET scan. Rising PSA, soft-tissue growth or new bone lesions showing that the cancer is growing.

Main reasons for not taking part

Other prostate cancer types, such as neuroendocrine or intraductal
Any earlier RLT or PSMA-targeted treatment
Other cancer treatments given at the same time or within 28 days of enrollment or randomization
Other investigational drugs within 28 days before the first dose
Brain metastases that were not treated or are not stable

Read by machine on 9 November 2026.

Where in Italy

ConaCona, ItalyTaking people
MilanMilan, ItalyTaking people
NaplesNaples, ItalyTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

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Trial details

Who runs it: Novartis Pharmaceuticals
Trial code: NCT07226986 EU 2025-521859-23-00
Record updated: 15 October 2026
Original description: 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.Read full original descriptionShow less
A Phase Ib/II Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen Receptor Pathway Inhibitor (ARPI) in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer (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 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.
Inclusion: Signed informed consent must be obtained prior to participation in the study; Participants must be adults ≥ 18 years of age; Participants must have an ECOG performance status of 0 to 2; Participants must have histologically confirmed adenocarcinoma of the prostate. Participants with other histology (e.g. neuroendocrine, intraductal subtype) are not eligible; Phase Ib: Prior exposure of up to 1 line of taxane-based chemotherapy is permissible. Phase II: Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting); Participants must have PSMA-PET positive disease assessed by using a PSMA imaging agent that is approved as per protocol and are eligible as determined by the sponsor's central reading rules; Castration level of testosterone (< 50 ng/dL), and/or use of concomitant ADT; Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI), based on at least 1 of the following criteria:; Serum/plasma PSA progression is defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng/mL; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication of progression as per PCWG3 guidelines; Soft-tissue progression defined PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016); Progression of bone disease: 2 new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria Scher et al 2016).
Exclusion: Concurrent local (radiation therapy to the prostate with curative intent or other prostate antineoplastic ablative procedures) or systemic (hormonal ablation, chemotherapy, immunotherapy, , RLTs) antineoplastic treatments, or within 28 days of enrollment (Phase Ib) or randomization (Phase II); Prior treatment with any RLT or PSMA-targeted agents (approved or investigational); Any other investigational agents within 28 days prior to first dose of any study treatment; Concurrent serious medical conditions that may interfere with study procedures or followup; Participants with a history of CNS metastases must have received therapy (surgery, whole brain radiation therapy, stereotactic radiosurgery) and be neurologically stable, asymptomatic, and not taking corticosteroids for the purpose of maintaining neurologic integrity; Other protocol-defined inclusion/exclusion criteria may apply.
ClinicalTrials.gov NCT07226986 · EU CTIS 2025-521859-23-00