GDC-1261 in advanced or metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a combined Phase 1/2 interventional trial evaluating GDC-1261 in men with advanced or metastatic prostate cancer. Participants will receive GDC-1261 and will be monitored for safety, how the drug is processed by the body, and any early signs of anti-tumor activity. The study aims to identify a recommended dose and regimen for future testing. Eligibility requires prior therapy with disease progression, ongoing or prior ADT, adequate organ function, and good performance status. Key exclusions include recent systemic therapy, untreated CNS metastases, uncontrolled pain, active infection, or recent cancer within the last five years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of \<=1
* Life expectancy is \>= 3 months
* Histologically or cytologically confirmed prostate adenocarcinoma
* Disease progression during or following the direct prior line of therapy
* Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy
* Metastatic disease
* Adequate end organ function

Exclusion Criteria:

* Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives
* Structurally unstable bone lesions suggest an impending fracture
* Untreated central nervous system (CNS) metastases or leptomeningeal disease
* Uncontrolled pain
* History of malignancy within 5 years
* Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection
* Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results

Where it's running

• Honor Health Research Institute
  Scottsdale, Arizona, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Sarah Cannon Research Institute
  Nashville, Tennessee, United States Recruiting
• St Vincent's Hospital Sydney
  Darlinghurst, New South Wales, Australia Recruiting
• Austin Hospital
  Heidelberg, Victoria, Australia Recruiting
• The Royal Marsden in Sutton, Surrey - Downs Rd
  Sutton, Surrey, United Kingdom Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: GO46445 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.