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RecruitingPhase 1

Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 48 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Duration of the study up to approximately 48 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests VIR-5500 (AMX-500) for prostate cancer, alone or with a drug that blocks male hormone signals. It looks at safety, how the body handles the drug, and early signs that it works. It is mainly for people whose cancer has spread and is growing despite treatment to lower male hormones, though some groups may accept other types of prostate cancer.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For Parts 1 and 2: Scans must show at least one area where the cancer has spread.
  • For Parts 1 and 2: The cancer must be growing despite treatment to lower male hormones. Growth must be shown by rising PSA blood tests, growth in lymph nodes or organs, or at least two new cancer spots on a bone scan.
  • For Parts 1 and 2: You must have taken at least one newer hormone-blocking drug, such as abiraterone, apalutamide, darolutamide, or enzalutamide.
  • For Parts 1 and 2: You must have had at least one taxane chemotherapy treatment, such as docetaxel or cabazitaxel.
  • For Parts 1 and 2: Standard treatment must be considered unsuitable for you.
  • For Parts 2, 3a, and 4a: Scans must show cancer that has spread and is growing despite treatment to lower male hormones, based on PSA tests or scans.
  • Some groups in Parts 2, 3a, and 4a may also accept cancer that has spread but still responds to hormone treatment, or cancer that has returned based on blood tests.

Who can't join

  • Your cancer is mainly one of these types seen under a microscope: sarcomatoid, spindle cell, or neuroendocrine small cell.
  • You have a short-term or long-term infection.
  • The study doctor thinks another health condition or inflammation could raise your risk of harm from VIR-5500.
  • You have cancer spots near vital organs.
  • You have known active cancer spread to the brain or spinal cord, or cancer in the tissues covering them.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (8)

CA

IL

TX

VA

WA