RightFit
RecruitingPhase 1 / Phase 2

A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer

A Phase I/II Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or Metastatic Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests GDC-1261 in people with prostate cancer that is advanced or has spread to other parts of the body. It looks at safety, how the body handles the drug, and early signs that it works. It also aims to find doses and a treatment schedule for future studies.

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Able to do daily activities with little or no limits on physical activity.
  • Expected to live at least 3 months.
  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue or cell test.
  • Cancer got worse during or after the most recent treatment.
  • Are taking hormone treatment to lower testosterone, or have had both testicles removed.
  • Cancer has spread to other parts of the body.
  • Major organs work well enough.

Who can't join

  • Received an approved cancer treatment that travels through the body within 14 days or within the time it takes the body to clear half the drug 5 times.
  • Have weakened areas of bone that may break soon.
  • Have untreated cancer that has spread to the brain or spinal cord, or cancer in the tissues covering them.
  • Have pain that is not controlled.
  • Have a history of cancer within the past 5 years.
  • Have any current infection, or needed antibiotics through a vein within 14 days or by mouth within 7 days before screening.
  • Have a health condition or abnormal lab result that the study doctor thinks could make the study unsafe, prevent completion, or affect the results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

AZ

TN