A Phase I, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer
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Study Summary
The study will be conducted in 4 parts and will commence with dose escalation of AMX-500 as a monotherapy (Part 1), followed by monotherapy dose expansion (Part 2). Part 1 (Monotherapy Dose Escalation): Single-agent AMX-500 dose escalation Part 2 (Monotherapy Dose Expansion): Single-agent AMX-500 dose expansion To assess the safety, pharmacokinetics and preliminary efficacy of VIR-5500 in combination with androgen receptor pathway inhibitors in first-line mCRPC To assess the safety, pharmacokinetics, and preliminary efficacy of VIR-5500 in participants with metastatic castration-resistant prostate cancer (mCRPC).
Objectives were to characterize safety, pharmacokinetics (PK) profiles, anti-tumor activity, and determine the dose(s)/regimen(s) for expansion.
To assess the safety, pharmacokinetics and preliminary ecacy of VIR-5500 in both early and late-line metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC)
To measure the safety and efficacy of VIR-5500 monotherapy in late-line mCRPC, and of VIR-5500 in combination with an androgen receptor pathway inhibitor (ARPI) in early-line mCRPC and mHSPC.
- Inclusion Criteria:
- Applicable to Parts 1 and 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 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
- 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)
- Are deemed unsuitable for standard of care
- Applicable to Part 2, 3a and Part 4a,
- 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
- 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.
- cabazitaxel) Participants deemed unsuitable for standard of care Has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Has a life expectancy more than 6 months
- Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell componentsHas acute or chronic infectionsHas a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500 (AMX-500),, per the InvestigatorHas lesions in proximity of vital organsHas 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.Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components Has acute or chronic infections Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to AMX 500, per the Investigator Has lesions in proximity of vital organs 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.
Clinical Study Information for Healthcare Providers
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