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.
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
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)
Exclusion criteria
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)
Trial sites
Chur, Lausanne, St. Gallen
(BASEC)
Sponsor
Amgen Inc. Thousand Oaks, CA, USA Amgen Switzerland AG, Rotkreuz
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Richard Cathomas
+41 81 256 66 46
richard.cathomas@clutterksgr.chKantonsspital Graubünden
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
29.08.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available