Hormone-refractory Prostate Cancer
Conditions
Keywords
Prostate Cancer, Castration Resistant Prostatic Cancer, High-Risk Biochemical Recurrent Prostate Cancer, Metastatic Castration-resistant Prostate Cancer (mCRPC), Hormone Sensitive Prostate Cancer (HSPC), Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Genital Diseases, Male, Genital Diseases, Urogenital Diseases, Prostatic Diseases, Male Urogenital Diseases, Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant
Brief summary
The study will be conducted in 4 parts and will commence with dose escalation of VIR-5500 as a monotherapy (Part 1), followed by combination escalation (Part 3a), monotherapy dose expansion (Part 2) and combination dose expansion (Part 4a). * Part 1 (Monotherapy Dose Escalation): Single-agent VIR-5500 dose escalation * Part 2 (Monotherapy Dose Expansion): Single-agent VIR-5500 dose expansion * Part 3 (Combination Dose Escalation): VIR-5500 plus another therapeutic agent dose escalation Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI) * Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion Part 4a (Combination Dose Expansion): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)
Detailed description
Duration of the study up to approximately 48 months.
Interventions
DRUGVIR-5500
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
Oral administration
Sponsors
Astellas Pharma Global Development, Inc.
Vir Biotechnology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Applicable to Parts 1 and 2 1. Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging 2. Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3) * PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart * Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications * Appearance of ≥ 2 new lesions in bone scan 3. Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide 4. Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) 5. Are deemed unsuitable for standard of care Applicable to Part 2, 3a and Part 4a, 1. Have metastatic CRPC, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging that has documented progressive disease (PD) based on ≥ 1 of the following criteria (per PCWG3): * PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart * Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications * Appearance of ≥2 new lesions in bone scan 2. Participants with metastatic hormone sensitive prostate cancer (mHSPC) or with biochemical recurrent prostate cancer (BRPC) may also participate in select cohorts of this clinical trial.
Exclusion criteria
1. Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components 2. Has acute or chronic infections 3. Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500 (AMX-500), per the Investigator 4. Has lesions in proximity of vital organs 5. Has known active CNS metastases and/or carcinomatous meningitis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to VIR-5500 | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months | Incidence and severity of AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) |
| Part 1 and 3a: Incidence of Dose Limiting Toxicities (DLTs) | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to Day 21 or Day 28 | Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) |
| Part 2 and 4a: Prostate-Specific Antigen (PSA) response rate | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months | — |
| Part 2 and 4a: Objective Response Rate (ORR) | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months | — |
| Part 1 and 3a: Number of participants with treatment-emergent Adverse Events (AEs) | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months | Incidence and severity of AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) |
Secondary
| Measure | Time frame |
|---|---|
| Part 2 and 4a: Number of participants with Adverse Events (AEs) | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| Part 1 and 3a: PSA response rate | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| Part 1 and 3a: Objective Response Rate (ORR) | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| All parts: Duration of response (DoR) | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| All parts: Progression Free Survival PFS | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| All parts: Assessment of PK parameters: Cmax | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| All parts: Assessment of PK parameters: AUC | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| All parts: Assessment of PK parameters: Tmax | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| All parts: Incidence of baseline anti-drug antibodies (ADAs) to VIR-5500 | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to VIR-5500 | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
Countries
Australia, Spain, United Kingdom, United States
Contacts
CONTACTStudy Inquiry
Outcome results
None listed