Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

Amgen

Status and phase

Enrolling

Phase 1

Conditions

Non-metastatic Castration-sensitive Prostate Cancer

High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer

Prostate Cancer

High-risk Biochemical Recurrence

Treatments

Drug: Xaluritamig

Study type

Interventional

Funder types

Industry

Identifiers

NCT06555796

20230238

Details and patient eligibility

About

The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).

Enrollment

40 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features.
Prostate cancer initially treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent.
PSA doubling time ≤ 12 months.
Participants must have biochemically recurrent disease after definitive treatment to prostate by either RP or XRT.
Screening PSA by the local laboratory ≥ 0.2 ng/mL for participants who had RP (with or without XRT) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir (local assessments) for participants who had XRT or brachytherapy only as primary treatment for prostate cancer.
Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).
Participants must have undergone a 68Ga-PSMA-11 or a piflufolastat F18 PET scan during or within 3 months of screening.

Exclusion Criteria

Present evidence of metastatic disease in conventional CT scan and/or bone scan
Participants that present prostate-specific membrane antigen (PSMA)-positive lesions in the 68Ga-PSMA-11 or the piflufolastat F18 positron emission tomography (PET) scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease.
Prior hormonal therapy, exceptions include:
- Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before enrollment, or
- A single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before enrollment.
Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, enzalutamide, apalutamide, or darolutamide for prostate cancer.
Abiraterone acetate, enzalutamide, apalutamide, or darolutamide are allowed if administered in a neoadjuvant/adjuvant setting ≤ 36 months in duration and ≥ 9 months before enrollment.
Prior systemic biologic therapy, including immunotherapy, for prostate cancer.
If, in the investigator's opinion, salvage therapy is the preferred intervention.
Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
Requirement for chronic systemic corticosteroid therapy (prednisone dose > 10 mg/day or equivalent) or any other immunosuppressive therapies (including anti tumor necrosis factor alpha [TNFα] therapies).