A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer
NCT07567846 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2026-05-05
Summary
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.
Conditions
Interventions
- DRUG
-
GDC-1261
Participants will receive GDC-1261 as per the schedule described in the protocol.
Sponsors & Collaborators
-
Genentech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Genentech, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-11-30
- Completion
- 2027-12-30
- FDA Drug
- Yes
More Related Trials
-
Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory Prostate Cancer
NCT00140400 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)
NCT00140387 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT04428788 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer
NCT00479635 ·Status: TERMINATED ·Phase: PHASE2
-
Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC
NCT04506567 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer
NCT02107391 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer
NCT07389174 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
A Study of FT-7051 in Men With MCRPC
NCT04575766 ·Status: TERMINATED ·Phase: PHASE1
-
Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer
NCT06014255 ·Status: RECRUITING ·Phase: PHASE2
-
A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients
NCT02691975 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer
NCT03150056 ·Status: TERMINATED ·Phase: PHASE1
-
Dose-finding Study of GSK2636771 When Administered in Combination With Enzalutamide in Male Subjects With Metastatic Castration-Resistant Prostate Cancer
NCT02215096 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
NCT01322490 ·Status: COMPLETED ·Phase: PHASE3
-
Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
NCT01325311 ·Status: COMPLETED ·Phase: PHASE2
-
Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy
NCT03725761 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
NCT01360840 ·Status: COMPLETED ·Phase: PHASE2
-
SHR7390 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
NCT04676607 ·Status: COMPLETED ·Phase: PHASE2
-
Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer
NCT00134355 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine
NCT00140348 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
NCT00075192 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
NCT00028769 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma
NCT07316686 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy
NCT00278993 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer
NCT02137746 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
NCT06801236 ·Status: RECRUITING ·Phase: PHASE1