Phase 1b Study to Assess the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with Metastatic Hormone-Sensitive Prostate Cancer.
Zusammenfassung der Studie
This is a Phase 1b study that is part of the early development phase in the evaluation of human medicinal products. The researchers aim to determine how safe and effective Xaluritamig is when used in combination with an ARPI (Androgen Receptor Pathway Inhibitor, which blocks androgens, i.e., male hormones that contribute to the growth of prostate cancer) such as Darolutamide and Abiraterone in participants with mHSPC. The effect of Xaluritamig is based on the activation of the body's immune system to combat cancer growth. The study may last up to about 36 months for each individual participant and includes a screening phase of up to 28 days, a treatment phase of 48 weeks, a safety follow-up visit 30 days after the last treatment day, and subsequent long-term follow-up (LTFU), with visits approximately every 24 weeks from the last treatment day. These LTFU visits will continue until 3 years from the first day of study treatment. During the LTFU phase, participants will also visit the study center every 12 weeks to provide a blood sample to monitor their PSA levels. Men aged 18 years or older who have recently been diagnosed with mHSPC will be included in the study. Participants must have started androgen deprivation therapy with or without an ARPI within the last 12 weeks prior to study participation. Participants whose PSA levels have risen since the start of ADT, who have other significant cancers, or who have received chemotherapy for prostate cancer are not eligible to participate in the study.
(BASEC)
Untersuchte Intervention
Depending on which treatment group they are assigned to by the study physician, participants will receive Xaluritamig either in combination with Darolutamide or in combination with Abiraterone. There are two treatment groups: Arm A: Xaluritamig is administered during the treatment phase as an intravenous infusion over approximately 60 minutes, along with orally taken Darolutamide. Arm B: Xaluritamig is administered during the treatment phase as an intravenous infusion over approximately 60 minutes, along with orally taken Abiraterone.
(BASEC)
Untersuchte Krankheit(en)
Metastatic hormone-sensitive prostate cancer (mHSPC) is an advanced form of prostate cancer in which the cells in the prostate grow uncontrollably, spread to other parts of the body such as bones, lymph nodes, and other organs, but respond to hormone treatment.
(BASEC)
Participants have provided informed consent, are ≥ 18 years old, and have a histologically, pathologically, and/or cytologically confirmed adenocarcinoma of the prostate. High-volume de novo mHSPC, defined as metastatic disease without a prior diagnosis of localized prostate cancer and initiation of ADT no longer than 12 weeks before screening, with or without ARPI (Abiraterone OR Darolutamide); high-volume is defined as the presence of visceral metastases and/or ≥ 4 bone metastases with at least one metastasis outside the spine and pelvis. Metastases must be documented by a positive bone scintigraphy or CT or MRI, depending on the type of metastasis. (BASEC)
Ausschlusskriterien
CNS metastases. Any prior targeted STEAP-1 therapy, radioligand therapy, treatment with PARP inhibitors, cytotoxic chemotherapy, aminoglutethimide, ketoconazole, or prior systemic biologic therapy (including immunotherapy) for prostate cancer. Prior treatment with enzalutamide or apalutamide within 15 days before enrollment in the study. Previous radiation therapy (except palliative radiation) to the prostate and/or metastases. Patients with other medical problems and/or medications that represent a contraindication for immunotherapy according to the study protocol. (BASEC)
Studienstandort
Chur, Lausanne, St Gallen
(BASEC)
Sponsor
Amgen Inc. Thousand Oaks, CA, USA Amgen Switzerland AG, Rotkreuz
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Richard Cathomas
+41 81 256 66 46
richard.cathomas@clutterksgr.chKantonsspital Graubünden
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
29.08.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Phase 1b Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with Metastatic Hormone-sensitive Prostate Cancer. (BASEC)
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ergebnisse der Studie
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