Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1/Phase 2
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2025
septembre 2029
24 juin 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | D�sir�e DEANDREIS | 10/07/2026 14:05:06 | Contacter | ||
Critères
Homme
- 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).
Key Exclusion Criteria:
- 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.