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A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer

ConditionsAdvanced Prostate CancerMetastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorGenentech, Inc.

About this trial

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.

Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).

Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen, unless otherwise specified.

Disqualifiers

Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, not to exceed 28 days) prior to the first study treatment.

Treatment with any investigational agent within 28 days prior to the first study treatment.

Treatment with any previous AR protein degrader.

Untreated central nervous system (CNS) metastases or leptomeningeal disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • RO7656594

    Drug

    RO7656594 will be administered orally at specified dose on specified days.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Stage 1: Dose EscalationExperimental treatment 1 intervention
Group B: Stage 2: ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants with Adverse Events

Time frame
From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
2

Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)

Time frame
Days 1-28 of Cycle 1

Secondary outcomes

1

Plasma Concentration of RO7656594

The pharmacokinetics (PK) of RO7656594 will be evaluated in plasma.

Time frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
2

Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594

Time frame
From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
3

Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594

Time frame
From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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