Hormone-refractory Prostate CancerPhase 1NCT05997615
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
A Phase 1 study testing VIR-5500, Androgen receptor signaling inhibitor (ARSI) and Docetaxel in people with Hormone-refractory Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 24 sites in 4 countries.
Trial summary
There are many treatment options for men with various stages of prostate cancer. Some treatments work well for a while but can cause medical problems in some men. Also, the cancer may come back after treatment. This is an early development study of VIR-5500 in men with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone-refractory Prostate Cancer
- What is being tested?
- VIR-5500, Androgen receptor signaling inhibitor (ARSI) and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 10 Aug 2023to 30 Jun 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion Criteria Applicable to mCRPC Cohorts in Part 1 and PSMA-Targeted Radioligand-Naive mCRPC Cohort (Part 2 Cohort 2-2)
- Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging
- Have had prior bilateral orchiectomy and/or are receiving androgen deprivation therapy (ADT) and have a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
- Have documented progressive mCRPC 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
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- Appearance of ≥ 2 new lesions in bone scan
- Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide
- Have been treated with ≥ 1 prior taxane regimens (example (e.g.), docetaxel, cabazitaxel) in either mHSPC or mCRPC setting
- Participants with known mutations in BRCA1/2 must have received a PARP inhibitor if an approved therapy is locally available, and participant is considered suitable for this therapy
- Are deemed unsuitable for standard of care (Only applicable for Part 1)
- Inclusion Criteria Applicable for PSMA-Targeted Radioligand-Experienced mCRPC Cohort Only (Part 2 Cohort 2-1)
- Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging
- Have 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
- Have had prior bilateral orchiectomy and/or are receiving ADT and have a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
- Have received PSMA-targeted radioligand-based therapy, such as 177Lu-PSMA-617 in any setting
- Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide
- Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) in either mHSPC or mCRPC setting
- Participants with known mutations in BRCA1/2 must have received a PARP inhibitor if an approved therapy is locally available, and participant is considered suitable for this therapy
- Inclusion Criteria Applicable for 1L/2L Taxane-Naïve mCRPC Cohorts Only (Cohort 2-3, Part 3, Cohort 4a-1, and Cohort 4b-1)
- Prior treatment with ARSI (including but not limited to abiraterone, enzalutamide, darolutamide, or apalutamide). Participants without prior ARSI treatment in the mCRPC setting are also allowed
- No prior exposure to taxane-based chemotherapy or other cytotoxic agents, including antibody-drug conjugates (ADCs) administered specifically for the treatment of mCRPC
- Participants with known mutations in BRCA1/2 must have received a PARP inhibitor if an approved therapy is locally available, and participant is considered suitable for this therapy
- Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging
- Have documented 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
- Have had prior bilateral orchiectomy and/or are receiving ADT and have a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
- Inclusion Criteria Applicable for mHSPC Cohorts Only (Part 3, Cohort 4a-2, and Cohort 4b-2)
- Histologically documented prostate adenocarcinoma which is de novo or recurrent and considered castration-sensitive
- Metastatic disease prior to first dose, with clear evidence of ≥ 1 bone lesion (defined as one lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment with CT and/or MRI. Participants with metastatic disease identified by PSMA-PET only, will not be eligible. Participants with disease limited to regional pelvic lymph nodes only are not eligible
- Participants should have high-risk OR high-volume disease per the following criteria:
- High-risk is defined as presence of at least 2 of the following: Gleason score of greater than or equal to (≥) 8; presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI
- High-volume disease is defined as: Presence of visceral metastases OR 4 bone lesions, with ≥1 beyond the vertebral bodies and pelvis
- Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and < 4 months prior to first dose with no radiographic evidence of disease progression or rising PSA levels prior to first day of dosing
- Inclusion Criteria Applicable for High-Risk BRPC Cohorts Only (Dose Optimization, Part 3a, and Part 4a-3)
- Have BRPC defined by meeting all of the following criteria:
- Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent
- PSA doubling time ≤ 12 months at the time of study entry
- Screening PSA ≥ 1 ng/mL in patients who have had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir in patients who had radiotherapy only as primary treatment for prostate cancer
- Screening serum testosterone > 150 ng/dL
- Inclusion Criteria Specific to Part 1a (Japanese Participants with mCRPC)
- Participant is of Japanese descent and will be participating at a site in Japan
- Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging
- Have had prior bilateral orchiectomy and/or are receiving an ADT and have a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
- Have documented progressive mCRPC 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
- Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including but not limited to abiraterone, apalutamide, darolutamide, and/or enzalutamide
- Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) in either the mHSPC or mCRPC setting
- Prior treatment with PSMA-targeted radioligand therapy, immunotherapy, sipuleucel-T, PARP inhibitors, and radium-223 is allowed
- Participants with known mutations in BRCA1/2 must have received a PARP inhibitor if an approved therapy is locally available, and participant is considered suitable for this therapy
- Inclusion Criteria Specific to Part 2a (Chinese Participants with mCRPC)
- Participant is of Chinese descent and will be participating at a site in China
- Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging
- Have had prior bilateral orchiectomy and/or are receiving ADT and have a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
- Have documented progressive mCRPC 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
- Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including but not limited to abiraterone, apalutamide, darolutamide, and/or enzalutamide
- Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) in either the mHSPC or mCRPC setting
- Prior treatment with PSMA-targeted radioligand therapy, immunotherapy, sipuleucel-T, PARP inhibitors, and radium-223 is allowed
- Participants with known mutations in BRCA1/2 must have received a PARP inhibitor if an approved therapy is locally available, and participant is considered suitable for this therapy
Who cannot join
- Have dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components
- Have acute or chronic infections
- Have a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500 (AMX-500)
- Have known active CNS metastases and/or carcinomatous meningitis
- Have lesions in proximity of vital organs
- Applicable to mHSPC cohorts only:
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- Any prior treatment with a GnRH analogue or ARSI
- Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer
- Exclusion Criteria Applicable to Part 3a and Part 4a Only: VIR-5500 (AMX-500) in Combination With an ARSI (Enzalutamide or Darolutamide)
- Are progressing rapidly while taking a second-generation androgen-signaling inhibitor
- Have a history or presence of clinically relevant CNS pathology within 12 months of enrollment
- Have had significant cardiovascular disease within the last 3 months
- Exclusion Criteria Applicable to Part 3b and Part 4b Only: VIR-5500 (AMX-500) in Combination With Docetaxel ± ARSI
- Abnormal liver function test (LFT) values during screening
- Currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Trial locations and contacts
24 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 4 countries
Spain11 sites, 10 recruiting
- Recruiting
ES34001
Barcelona
- Recruiting
ES34007
Barcelona
- Withdrawn
ES34015
Barcelona
- Recruiting
ES34010
Logroño
- Recruiting
ES34003
Madrid
- Recruiting
ES34012
Madrid
- Recruiting
ES34013
Málaga
- Recruiting
ES34004
Pamplona
- Recruiting
ES34002
Pozuelo de Alarcón
- Recruiting
ES34005
Sabadell
- Recruiting
ES34009
Valencia
United States9 sites, 9 recruiting
- Recruiting
Duarte Cancer Center
Duarte, California, 91010
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Lennar Foundation Cancer Center
Irvine, California, 92618
- Recruiting
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, 92862
- Recruiting
Stanford University
Palo Alto, California, 94304
- Recruiting
University of California
San Francisco, California, 94115
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
- Recruiting
Chicago Cancer Center
Zion, Illinois, 60099
Australia2 sites, 2 recruiting
- Recruiting
AU61002
Darlinghurst
- Recruiting
AU61001
Melbourne
United Kingdom2 sites, 2 recruiting
- Recruiting
GB44003
Leicester
- Recruiting
GB44001
London
About this study
Official title: A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer
There are many treatment options for men with various stages of prostate cancer. Some treatments work well for a while but can cause medical problems in some men. Also, the cancer may come back after treatment.
This is an early development study of VIR-5500 in men with prostate cancer. In this study, VIR-5500 will be given to people for the first time. VIR-5500 will either be given by itself or given together with one or more standard cancer treatments: enzalutamide, darolutamide and docetaxel. Some other cancer treatments may also be given with VIR-5500 during this study, depending on results from other ongoing studies.
Read more
Early development studies are mostly about safety, but also to find the most suitable dose. Other aims are to check if VIR-5500 shows signs of reducing tumor growth and to learn how the body processes VIR-5500. This will be done both for VIR-5500 given by itself and given together with the other cancer treatments.
The main aim(s) of the study are to check the safety of different doses of VIR-5500 when given by itself and given together with the standard cancer treatments, and how well it is tolerated; to find a suitable dose of VIR-5500 when given by itself and given together with the standard cancer treatments; to check the safety of VIR-5500 when given by itself to people in China and Japan; and to check how well VIR-5500 controls tumors when given by itself and given together with the standard cancer treatments.
Adult men with certain types of advanced prostate cancer can take part. Their cancer has spread to other parts of the body (metastatic). The different types of cancer in this study are: Metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer that needs testosterone to grow; Metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer that continues to grow even when testosterone levels are low; and High-risk biochemical recurrent prostate cancer (high-risk BRPC). Biochemical recurrence is a rise in PSA levels after treatment for prostate cancer. Men whose PSA levels double in less than 1 year are considered high risk of the cancer coming back and quickly getting worse.
In this study, VIR-5500 will be given to people for the first time. VIR-5500 will either be given itself or given together with at least one of the standard cancer treatments: enzalutamide, darolutamide, and docetaxel. The standard cancer treatment given will depend on which part of the study the men are in, and what type of prostate cancer they have. Other cancer treatments may be given, depending on results from other ongoing studies.
The study will have 4 parts.
In Part 1, different small groups of men with Metastatic castration-resistant prostate cancer (mCRPC) will receive lower to higher doses of VIR-5500 given by itself. Any medical problems will be recorded for each dose. This is to find out suitable doses to use in Part 2 of the study.
In Part 2, other small groups of men with mCRPC will receive the suitable doses of VIR-5500 worked out from Part 1. These men will have previously received specific cancer treatments before starting this study.
In Part 3, other different small groups of men with metastatic hormone-sensitive prostate cancer (mHSPC), mCRPC or high-risk BRPC will receive lower to higher doses of VIR-5500 given by itself or given with the other standard cancer treatments. They will be given VIR-5500 with enzalutamide or darolutamide, VIR-5500 with docetaxel, VIR-5500 with docetaxel and enzalutamide, or VIR- 5500 with docetaxel and darolutamide. Any medical problems will be recorded for each dose. This is to find out suitable doses to use in Part 4 of the study.
In Part 4, other small groups of men with mHSPC, mCRPC or high-risk biochemical recurrent prostate cancer (BRPC) will receive the suitable doses of VIR-5500 given together with the standard cancer treatments, worked out in Part 3. They will be given VIR-5500 with enzalutamide, VIR-5500 with darolutamide, VIR-5500 with docetaxel and enzalutamide, or VIR-5500 with docetaxel and darolutamide. The standard cancer treatment given will depend on their previous treatment before joining the study and the type of prostate cancer they have.
- Conditions
- Hormone-refractory Prostate Cancer
- Being tested
- VIR-5500, Androgen receptor signaling inhibitor (ARSI), Docetaxel
- 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
- Medical subject headings
- Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Genital Diseases, Male, Genital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-5500Drug
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
Androgen receptor signaling inhibitor (ARSI)Drug
Oral administration
DocetaxelDrug
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: VIR-5500 Monotherapy Dose Escalation | Experimental | VIR-5500 will be administered as a monotherapy in participants with mCRPC over a 21-day, 28-day or 42-day cycle. Receives: Drug: VIR-5500 |
| Part 1a: VIR-5500 Monotherapy Japan Safety and PK Cohort | Experimental | VIR-5500 will be administered as a monotherapy in Japanese participants with mCRPC over a 21-day, 28-day or 42-day cycle. Receives: Drug: VIR-5500 |
| Part 2: VIR-5500 Monotherapy Dose Expansion | Experimental | VIR-5500 will be administered as a monotherapy in participants with mCRPC over a 21-day, 28-day or 42-day cycle. Receives: Drug: VIR-5500 |
| Part 2a: VIR-5500 Monotherapy China Safety and PK Expansion Cohort | Experimental | VIR-5500 will be administered as a monotherapy in Chinese participants with mCRPC over a 21-day. 28-day or 42-day cycle. Receives: Drug: VIR-5500 |
| Part 3a: VIR-5500 in Combination with an ARSI for Dose Escalation | Experimental | VIR-5500 will be administered in combination with ARSI over a 21-day or 28-day cycle. ARSI will be administered every day. Receives: Drug: VIR-5500; Drug: Androgen receptor signaling inhibitor (ARSI) |
| Part 3b: VIR-5500 in Combination with Docetaxel ± ARSI for Dose Escalation | Experimental | VIR-5500 will be administered in combination with docetaxel ± ARSI over a 21-day or 28-day cycle. Docetaxel will be administered once every 3 weeks for a maximum of 10 cycles for mCRPC and 6 cycles for mHSPC participants. ARSI may be included in the regimen at any stage administered per local label. Receives: Drug: VIR-5500; Drug: Androgen receptor signaling inhibitor (ARSI); Drug: Docetaxel |
| Part 4a: VIR-5500 in Combination with an ARSI for Dose Expansion | Experimental | VIR-5500 will be administered in combination with ARSI over a 21-day or 28-day cycle. ARSI will be administered twice daily. Receives: Drug: VIR-5500; Drug: Androgen receptor signaling inhibitor (ARSI) |
| Part 4b: VIR-5500 in Combination with Docetaxel ± ARSI for Dose Expansion | Experimental | VIR-5500 will be administered in combination with docetaxel ± ARSI over a 21-day or 28-day cycle. Docetaxel will be administered once every 3 weeks for a maximum of 10 cycles for mCRPC and 6 cycles for mHSPC participants. ARSI may be included in the regimen at any stage administered per local label. Receives: Drug: VIR-5500; Drug: Androgen receptor signaling inhibitor (ARSI); Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1, 1a, 2a and Part 3: Number of Participants With Adverse Events (AEs) (mCRPC, mHSPC and BRPC)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study intervention.
Measured: Up to 80 months
Part 1, 1a, 2a and Part 3: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (mCRPC, mHSPC and BRPC)
TEAEs are adverse events that developed, worsened, or became serious from the start date of study treatment to the end date of study treatment plus (+) 30 days.
Measured: Up to 80 months
Part 1, 1a and Part 3: Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT is defined as any event meeting the DLT criteria.
Measured: Up to 28 Days
Part 2 and 4: Prostate-Specific Antigen (PSA) Response Rate (PSA50) (mCRPC and mHSPC)
PSA50 response rate is defined as a ≥ 50% reduction in PSA from baseline confirmed to be sustained by a second PSA value obtained 3 or more weeks later.
Measured: Up to 80 months
Part 2 and 4: Objective Response Rate (ORR) (mCRPC and mHSPC)
ORR is defined as a proportion of participants who have complete response (CR) or partial response (PR) per investigator assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications.
Measured: Up to 80 months
Part 4: PSA50 Response Rate (BRPC)
PSA50 response rate is defined as a ≥ 50% reduction in PSA from baseline confirmed to be sustained by a second PSA value obtained 3 or more weeks later.
Measured: Up to 80 months
Part 4: Duration of PSA50 Response (BRPC)
PSA50 is defined as a ≥ 50% reduction in PSA from baseline confirmed to be sustained by a second PSA value obtained 3 or more weeks later. Duration of PSA50 response is defined as the period from the date of first documented >= 50% reduction in PSA to the date of first documented < 50% reduction in PSA, disease progression or death due to cause.
Measured: Up to 80 months
Secondary outcomes (22)
Part 2 and 4: Number of Participants With Adverse Events (AEs) (mCRPC, mHSPC and BRPC)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.
Measured: Up to 80 months
Part 1, 1a, 2a and 3: Confirmed PSA50 Response Rate (mCRPC and mHSPC)
PSA50 response rate is defined as a ≥ 50% reduction in PSA from baseline confirmed to be sustained by a second PSA value obtained 3 or more weeks later.
Measured: Up to 80 months
All Parts: Confirmed PSA90 Response Rate (mCRPC, mHSPC and BRPC)
PSA90 response rate is defined as a ≥ 90% reduction in PSA from baseline confirmed to be sustained by a second PSA value obtained 3 or more weeks later.
Measured: Up to 80 months
Part 1, 1a, 2a and 3: Objective Response Rate (ORR) (mCRPC and mHSPC)
ORR is defined as a proportion of participants who have either CR or PR per investigator assessment using the RECIST v1.1 with PCWG3 modifications.
Measured: Up to 80 months
Part 1, 1a, 2, 2a, 3 and 4: Time to Response (TTR) (mCRPC and mHSPC)
Time to response (TTR) is defined as the period from Cycle 1 Day 1 (C1D1) to the date of first either CR or PR per investigator assessment using the RECIST v1.1 with PCWG3 modifications.
Measured: Up to 80 months
Part 1, 1a, 2, 2a, 3 and 4: Duration of Response (DOR) (mCRPC and mHSPC)
Duration of response (DOR) is defined as the period from the date of first CR or PR per investigator assessment using the RECIST v1.1 with PCWG3 modifications to disease progression or death, whichever occurs first.
Measured: Up to 80 months
Part 1, 1a, 2, 2a, 3 and 4: Radiographic Progression-Free Survival (PFS) (mCRPC and mHSPC)
Radiographic progression-free survival (PFS) is defined as the period from C1D1 to disease progression or death, whichever occurs first, as evaluated by investigator assessment per RECIST v1.1 and PCWG3 criteria.
Measured: Up to 80 months
All Parts: Time to PSA Progression (mCRPC, mHSPC and BRPC)
Time to PSA progression per PCWG3 criteria, defined as an increase in PSA greater than 25% and > 2 ng/mL above nadir.
Measured: Up to 80 months
Part 1, 1a, 2, 2a, 3 and 4: Duration of PSA50 Response (mCRPC and mHSPC)
PSA50 is defined as a ≥ 50% reduction in PSA from baseline confirmed to be sustained by a second PSA value obtained 3 or more weeks later. Duration of PSA50 response is defined as the period from the date of first documented ≥ 50% reduction in PSA to the date of first documented < 50% reduction in PSA, disease progression, or death due to any cause.
Measured: Up to 80 months
All Parts: Duration of PSA90 Response (mCRPC, mHSPC and BRPC)
PSA90 response rate is defined as a ≥ 90% reduction in PSA from baseline confirmed to be sustained by a second PSA value obtained 3 or more weeks later.
Duration of PSA90 response is defined as the period from the date of first documented ≥ 90% reduction in PSA to the date of first documented < 90% reduction in PSA, disease progression, or death due to any cause.
Measured: Up to 80 months
Part 2 and 4: Rate for Undetectable PSA (mHSPC)
Rate of undetectable PSA is defined as the proportion of participants who have a PSA of < 0.2 ng/mL at 6 and 8 months.
Measured: Up to 8 months
Part 4: Rate for Undetectable PSA (BRPC)
Rate of undetectable PSA is defined as the proportion of participants who have a PSA of < 0.2 ng/mL at 6, 12, and 24 months.
Measured: Up to 24 months
All Parts: Pharmacokinetics (PK) of VIR-5500 in Plasma: Area Under the Concentration Time Curve (AUC) (mCRPC, mHSPC and BRPC)
AUC will be recorded from PK plasma samples collected.
Measured: Up to 80 months
All Parts: PK of VIR-5500 in Plasma: Maximum Observed Concentration (Cmax) (mCRPC, mHSPC and BRPC)
Cmax will be recorded from PK plasma samples collected.
Measured: Up to 80 months
All Parts: PK of VIR-5500 in Plasma: Time to Reach Maximum Concentration (tmax) (mCRPC, mHSPC and BRPC)
Tmax will be recorded from PK plasma samples collected.
Measured: Up to 80 months
All Parts: PK of VIR-5500 in Plasma: Trough Concentration (Ctrough) (mCRPC, mHSPC and BRPC)
Ctrough will be recorded from PK Plasma samples collected.
Measured: Up to 80 months
All Parts: Accumulation Ratio of VIR-5500 (mCRPC, mHSPC and BRPC)
Accumulation ratio will be recorded from PK Plasma samples collected.
Measured: Up to 80 months
All Parts: PK of VIR-5500 Metabolite in plasma: AUC (mCRPC, mHSPC and BRPC)
AUC will be recorded from PK plasma samples collected.
Measured: Up to 80 months
All Parts: PK of VIR-5500 Metabolite in Plasma: Cmax (mCRPC, mHSPC and BRPC)
Cmax will be recorded from PK plasma samples collected.
Measured: Up to 80 months
All Parts: PK of VIR-5500 Metabolite in plasma: tmax (mCRPC, mHSPC and BRPC)
Tmax will be recorded from PK plasma samples collected.
Measured: Up to 80 months
All Parts: PK of VIR-5500 metabolite in plasma: Ctrough (mCRPC, mHSPC and BRPC)
Ctrough will be recorded from PK Plasma samples collected.
Measured: Up to 80 months
All Parts: Accumulation Ratio of VIR-5500 metabolite (mCRPC, mHSPC and BRPC)
Accumulation ratio will be recorded from PK Plasma samples collected.
Measured: Up to 80 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start10 Aug 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone-refractory Prostate CancerStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 347 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vir Biotechnology, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997615
- Sponsor's protocol ID
- VIR-5500-V101
- Other IDs
- U1111-1287-6968, 2023-503495-24, AMX-500, 2023
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.