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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT05800665
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Prostate Cancer
  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7656594 — DRUG
    RO7656594 will be administered orally at specified dose on specified days.

Study Details

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.

Key Dates

Start date
May 2, 2023
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
210 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Stage 1: Dose Escalation
    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.
  • Experimental: Stage 2: Expansion
    Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Primary Outcome Measure

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) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258-
Yale Cancer CenterNew HavenConnecticut06510-
Sarah Cannon Research Institute @ Florida CancerOrlandoFlorida32827-
University of Illinois Hospital & Health Sciences SystemChicagoIllinois60612-
SCRI Oncology PartnersNashvilleTexas37203-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth· Scottsdale, AZYale Cancer Center· New Haven, CTSarah Cannon Research Institute @ Florida Cancer· Orlando, FLUniversity of Illinois Hospital & Health Sciences System· Chicago, ILSCRI Oncology Partners· Nashville, TX

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