A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GDC-1261.
- Who it may be relevant to
- Registry conditions: Advanced Prostate Cancer, Metastatic Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug GDC-1261
Participants will receive GDC-1261 as per the schedule described in the protocol.
Primary outcome measures
- Percentage of Participants With Adverse Events (AEs) [Time frame: Up to approximately 24 months]
- Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs) [Time frame: From Day 1-28 of Cycle 1 (1 Cycle = 28 days)]
Secondary outcome measures (7)
- Plasma Concentration of GDC-1261 [Time frame: Up to approximately 24 months]
- Plasma Concentration of GDC-1261 Either in Fasted or Fed State [Time frame: Up to approximately 24 months]
- Prostate-Specific Antigen-30% (PSA30) Response Rate [Time frame: Up to approximately 24 months]
- PSA50 Response Rate [Time frame: Up to approximately 24 months]
- PSA90 Response Rate [Time frame: Up to approximately 24 months]
- Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
- Recommended Dose of GDC-1261 [Time frame: Up to approximately 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Honor Health Research Institute — Scottsdale
- Sarah Cannon Research Institute — Nashville
Australia · 2 centers
- St Vincent's Hospital Sydney — Darlinghurst
- Austin Hospital — Heidelberg
Identifiers
NCT: NCT07567846 · GO46445