Back to resultsA Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Primary Purpose
Advanced Prostate Cancer, Metastatic Prostate Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO7656594
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Prostate Cancer focused on measuring Castration-resistant
Eligibility Criteria
Key Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features. Prior therapy with ≥1 second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). Prior therapy with ≥1 taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen. Key Exclusion Criteria: 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. Note: Other protocol specified inclusion/exclusion criteria may apply.
Sites / Locations
- HonorHealthRecruiting
- Florida Cancer Specialists & Research Institute - Lake Nona Cancer CenterRecruiting
- Tennessee Oncology NASH - SCRI - PPDSRecruiting
- St Vincents HospitalRecruiting
- Seoul National University HospitalRecruiting
- Asan Medical Center - PPDSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Stage 1: Dose Escalation
Stage 2: Expansion
Arm Description
Participants will receive RO7656594 administered at a specified dose on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached.
Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Outcomes
Primary Outcome Measures
Percentage of Participants with Adverse Events
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Secondary Outcome Measures
Plasma Concentration of RO7656594
Area Under Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of RO7656594
Area Under Concentration-Time Curve From Time Zero to End of the Dosing Interval (AUC0-T) of RO7656594
Maximum Plasma Concentration Observed (Cmax) of RO7656594
Time to Maximum Plasma Concentration Observed (tmax) of RO7656594
Minimum Plasma Concentration Observed (Cmin) of RO7656594
Total Apparent Clearance of RO7656594
Volume of Distribution at Steady State of RO7656594
Half-life of RO7656594
Accumulation Ratio at Steady-State of RO7656594
Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594
Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05800665
Brief Title
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
Official Title
A Phase 1, Open-Label, Multicenter, Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 in Patients With Advanced or Metastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
July 30, 2026 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Prostate Cancer, Metastatic Prostate Cancer
Keywords
Castration-resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stage 1: Dose Escalation
Arm Type
Experimental
Arm Description
Participants will receive RO7656594 administered at a specified dose on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached.
Arm Title
Stage 2: Expansion
Arm Type
Experimental
Arm Description
Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Intervention Type
Drug
Intervention Name(s)
RO7656594
Other Intervention Name(s)
GDC-2992
Intervention Description
RO7656594 will be administered orally at specified dose on specified days.
Primary Outcome Measure Information:
Title
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)
Title
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Time Frame
Days 1-28 of Cycle 1
Secondary Outcome Measure Information:
Title
Plasma Concentration of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
Area Under Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
Area Under Concentration-Time Curve From Time Zero to End of the Dosing Interval (AUC0-T) of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
Maximum Plasma Concentration Observed (Cmax) of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
Time to Maximum Plasma Concentration Observed (tmax) of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
Minimum Plasma Concentration Observed (Cmin) of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
Total Apparent Clearance of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
Volume of Distribution at Steady State of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
Half-life of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
Accumulation Ratio at Steady-State of RO7656594
Time Frame
Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days)
Title
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)
Title
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)
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
Prior therapy with ≥1 second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
Prior therapy with ≥1 taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen.
Key Exclusion Criteria:
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.
Note: Other protocol specified inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GO44537 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists & Research Institute - Lake Nona Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology NASH - SCRI - PPDS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1503
Country
United States
Individual Site Status
Recruiting
Facility Name
St Vincents Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
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