20230005 A Phase III Study of Xaluritamig Compared to Cabazitaxel or Second Androgen Receptor-Directed Therapy in Patients with Advanced, Metastatic, Castration-Resistant Prostate Cancer
Summary description of the study
A total of approximately 675 participants will be enrolled from about 150–200 hospitals/facilities in Europe, North America, Asia, and Australia, randomized in a 2:1 ratio (450:225 patients) to receive either Xaluritamig as monotherapy (test group) or Cabazitaxel or a second androgen receptor-directed therapy (ARDT) at the discretion of the investigator (control group). Approximately 22 patients are planned for the study in Switzerland. Randomization will be stratified by: • either low or high lactate dehydrogenase (LDH) • presence of liver metastases (yes versus no) • previous treatment with PSMA (prostate-specific membrane antigen) radioligand therapy (yes versus no) • planned treatment according to the intention-to-treat principle (ITT) with Cabazitaxel versus second ARDT Enrollment in the ITT groups with Cabazitaxel versus second ARDT will be distributed equally (i.e., 50%/50%) across the two stratification factors. The study may last up to approximately 56 months for each patient, including a screening phase of up to 28 days, a treatment phase, and a follow-up phase lasting approximately 36 months. The actual treatment duration depends on how well patients tolerate or respond to the study treatments. The study will end 3 years after the last patient is randomized. After treatment, safety follow-up visits will occur 30 (+3) days after the last dose of the study drug, with long-term follow-up visits every 8 weeks (± 7 days) for the first 12 months and then every 12 weeks (± 14 days) for up to 3 years.
(BASEC)
Intervention under investigation
Patients will be randomly assigned to different treatment arms. There is a 2:3 chance of receiving Xaluritamig and a 1:3 chance of being assigned to the control arm with standard therapy (Cabazitaxel or second ARDT at the dosage according to regionally approved schemes or practice guidelines), with the standard therapy determined by the investigator after eligibility criteria are met and screening examinations are completed. The first dose of the study drug must be administered ≤ 10 days after randomization.
If patients are assigned to the Xaluritamig group, they will receive the study drug in the first treatment month once weekly as a short infusion directly into the vein, each lasting approximately 60 minutes. The dose will be gradually increased in 3 steps until the target dose of 1.5 mg is reached. After reaching the target dose, patients will receive Xaluritamig every 2 weeks (Day 1 and Day 15) for the remainder of the treatment duration.
In the standard treatment group, patients will receive either daily Abiraterone or Enzalutamide tablets to take or Cabazitaxel as a one-hour intravenous infusion directly into the vein every 3 weeks, depending on the physician's recommendation.
(BASEC)
Disease under investigation
Xaluritamig works by activating the body's immune system to combat cancer growth. In particular, Xaluritamig helps activate T-cells (a type of immune cell) to attack prostate cancer cells by creating a connection between proteins that are only present on the surface of certain types of T-cells and specific prostate cancer cells. The aim of the study is to compare the safety and efficacy of Xaluritamig with other standard therapies such as chemotherapy (Cabazitaxel) or androgen receptor-directed therapy (ARDT – Abiraterone acetate or Enzalutamide) in patients with metastatic castration-resistant prostate cancer (mCRPC). Xaluritamig is based on preclinical data and clinical evidence for efficacy with a manageable safety profile in patients with mCRPC (first-in-human study). Based on the available data, Xaluritamig is being developed as an option to improve treatment outcomes and survival in mCRPC with prior taxane treatment.
(BASEC)
Patients will be included in the study if they meet the following criteria: - Provide informed consent and are ≥ 18 years old, with a histologically, pathologically, and/or cytologically confirmed adenocarcinoma of the prostate. - mCRPC with ≥ 1 metastatic lesion detected at baseline by computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy, with imaging performed within 28 days prior to enrollment in the study. - Evidence of progressive disease as defined in the study protocol. (BASEC)
Exclusion criteria
- Any cancer therapy, immunotherapy, or any experimental drug within 4 weeks prior to the first dose of study treatment, except for androgen suppression therapy. - PSMA radioligand therapy, radionuclide therapy, or radiation therapy prior to the first dose of study treatment. - Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitors (a specific type of targeted cancer therapy), biologics, or investigational therapy. (BASEC)
Trial sites
Bellinzona, Bern, 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 Departement Innere Medizin
(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
29.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Studientitel: Eine offene, randomisierte, multizentrische Phase-III-Studie von Xaluritamig im Vergleich zu Cabazitaxel oder einer zweiten Androgenrezeptor-gerichteten Therapie bei Patienten mit metastasiertem, kastrationsresistentem Prostatakrebs, die zuvor mit Chemotherapie behandelt wurden (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