New hope for advanced prostate cancer: experimental drug GDC-1261 enters trials
NCT ID NCT07567846
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times
Summary
This study tests a new drug called GDC-1261 in 260 people with advanced or metastatic prostate cancer that has worsened after prior treatment. The goal is to check the drug's safety, find the best dose, and see if it can shrink tumors or lower PSA levels. Participants must already be on hormone therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Austin Hospital
RECRUITINGHeidelberg, Victoria, 3084, Australia
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Honor Health Research Institute
RECRUITINGScottsdale, Arizona, 85258-4566, United States
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Sarah Cannon Research Institute
RECRUITINGNashville, Tennessee, 37203, United States
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St Vincent's Hospital Sydney
RECRUITINGDarlinghurst, New South Wales, 2010, Australia
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The Royal Marsden in Sutton, Surrey - Downs Rd
RECRUITINGSutton, Surrey, SM2 5PT, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody aims to preserve immune checkpoint while fighting cancer
- Two-Drug combo targets prostate cancer that outsmarts hormone therapy
- AI chatbot may calm nerves after a prostate cancer diagnosis
- Can a new daily pill slow advanced prostate cancer?
- Can a common diabetes drug slow prostate cancer progression?
- Chemo combo vs. radioactive drug: which tames aggressive prostate cancer?