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RecruitingLast updated: 4 May 2026

CAMO959A12103: Evaluating a new medicine when given together with other standard treatments (radiation therapy and hormone therapy) for people with metastatic castration-resistant prostate cancer that is PSMA-positiveA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

CAMO959A12103

Clinical summary

Summary

This clinical study is testing a new medicine called AMO959 together with:

  • an approved radiation therapy treatment called lutetium-177 PSMA-617 (also known as 177Lu-PSMA-617 or AAA617),
  • and a standard hormone treatment called an androgen receptor pathway inhibitor (ARPI), such as abiraterone or enzalumatamide.

Who is it for?
You may be eligible for this study if you have advanced prostate cancer that has spread (metastatic) or is no longer responding to standard hormone therapy (castration resistant), and is PMSA-positive. You should also have failed treatment with one prior ARPI.

The study has two parts.

Phase Ib
To be eligible for this part of the study, participants may or may not have had prior chemotherapy treatment (taxane).

The goal of this part is to check whether the combination of medicines is safe, understand how well it is tolerated, learn how the drug AMO959 moves through the body, and find the best dose of AMO959 to use in the next phase of the study.

Small groups of participants will receive different doses of AMO959. Participants will first receive AMO959 alone, then AMO959 together with AAA617, with or without a standard hormone therapy (abiraterone or enzalutamide). 

Doctors will carefully monitor side effects before deciding whether to move to a higher dose. 

Phase II
Participants in this part of the study should have tried one prior hormone therapy (ARPI), but not have received any chemotherapy yet.

The goal of this part is to see how well the treatment works against prostate cancer.

Participants will be randomly assigned (by chance) to receive treatment with:

  • AMO959 + AAA617 + APRI (abiraterone or enzalutamide)
  • AAA617 + ARPI (abiraterone or enzalutamide)

Conditions

This trial is treating people with PSMA-positive metastatic castration-resistant prostate cancer

Eligibility

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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You are currently being treated on a clinical trial.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Novartis Pharmaceuticals

Scientific Title

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)

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