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Monoclonal Antibodies
RO7656594 for Prostate Cancer
Phase 1
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 1 day 1 until 28 days after the final dose (up to approximately 24 months) (1 cycle= 28 days)
Awards & highlights
Study Summary
This trial will assess a new drug to treat prostate cancer, to see if it's safe and effective. It will help decide the best dose and regimen.
Who is the study for?
This trial is for men with advanced or metastatic prostate cancer who have already tried at least one second-generation hormone therapy and a taxane chemotherapy, unless they can't tolerate or refused the chemo. They should be relatively active and able to care for themselves (ECOG ≤1).Check my eligibility
What is being tested?
The study is testing RO7656594's safety, how it affects the body, and its effectiveness in treating prostate cancer. Participants will receive different doses of RO7656594 to find out what amount works best for future studies.See study design
What are the potential side effects?
Possible side effects of RO7656594 are not specified here but generally may include typical reactions like nausea, fatigue, allergic responses, or other drug-specific effects which will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from cycle 1 day 1 until 28 days after the final dose (up to approximately 24 months) (1 cycle= 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 1 day 1 until 28 days after the final dose (up to approximately 24 months) (1 cycle= 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
Percentage of Participants with Adverse Events
Secondary outcome measures
Plasma Concentration of RO7656594
Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594
Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stage 2: ExpansionExperimental Treatment1 Intervention
Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Group II: Stage 1: Dose EscalationExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
567,983 Total Patients Enrolled
17 Trials studying Prostate Cancer
6,210 Patients Enrolled for Prostate Cancer
Clinical TrialsStudy DirectorGenentech, Inc.
2,201 Previous Clinical Trials
888,780 Total Patients Enrolled
3 Trials studying Prostate Cancer
417 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases or leptomeningeal disease that hasn't been treated.I haven't had cancer treatment in the last 14 days or within the drug's elimination period.I am fully active and can carry on all pre-disease activities without restriction.My prostate cancer has spread and is not small-cell or neuroendocrine type.I have been treated with a specific prostate cancer medication before.I have either been treated with a taxane, cannot receive taxane treatment, or have refused it.I have not been treated with AR protein degraders before.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1: Dose Escalation
- Group 2: Stage 2: Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks does Stage 1: Dose Escalation pose for human subjects?
"Our team at Power has determined that the safety of Phase 1: Dose Escalation is a score of 1, as this type of trial typically involves limited data regarding efficacy and protection."
Answered by AI
Have any opportunities to participate in this clinical investigation been closed off?
"Affirmative, the entry on clinicaltrials.gov illustrates that this clinical trial is recruiting participants after posting initially on April 28th 2023 and adjusting its details most recently on April 13th 2023. The research requires 160 volunteers from a single medical center."
Answered by AI
What is the current scope of test subjects being evaluated in this trial?
"Affirmative, according to clinicaltrials.gov the trial is still accepting applicants. It was initially uploaded on April 28th 2023 and has since been updated as of April 13th 2023. This experiment requires 160 individuals from a single medical facility."
Answered by AI
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