260 Participants NeededMy employer runs this trial

GDC-1261 for Prostate Cancer

Recruiting at 4 trial locations
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Overseen ByFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: Genentech, Inc.
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GDC-1261 for individuals with advanced or metastatic prostate cancer. Researchers aim to determine its safety and effectiveness in treating this cancer type. They also seek to identify the optimal dosage for future studies. This trial may suit those whose prostate cancer has spread, who have undergone treatment to lower male hormones, and whose cancer has worsened after their last therapy. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any approved systemic anti-cancer therapy at least 14 days before starting the study. However, ongoing androgen deprivation therapy (ADT) is allowed.

Is there any evidence suggesting that GDC-1261 is likely to be safe for humans?

Research shows that GDC-1261 is undergoing tests to determine its safety for individuals with advanced or spreading prostate cancer. Scientists are collecting data on its tolerability. In these early trials, the primary aim is to understand the drug's effects on the body and identify any side effects. Currently, detailed safety information about GDC-1261 in humans is not available. As this is the first human trial, researchers are still gathering comprehensive safety data. Participation in this trial helps researchers learn more about the treatment and its effects on the human body.12345

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about GDC-1261 for prostate cancer because it offers a fresh approach compared to current treatments like hormone therapy, chemotherapy, and radiation. Unlike these standard options that primarily focus on reducing or blocking hormones or killing fast-growing cells, GDC-1261 targets specific pathways responsible for cancer cell growth and survival. This precision might not only increase its effectiveness but also potentially reduce side effects, making it a promising alternative for patients.

What evidence suggests that GDC-1261 might be an effective treatment for prostate cancer?

Researchers are investigating GDC-1261 as a potential treatment for advanced or metastatic prostate cancer. Early results suggest it targets specific parts of cancer cells, potentially slowing or reducing tumor growth. Some early studies have shown that similar treatments can help manage advanced prostate cancer. This trial aims to understand the effect of GDC-1261 on cancer progression and determine the most effective dosage through a dose escalation and expansion study. While solid evidence on GDC-1261's efficacy is still being gathered, the research focuses on its impact on cancer progression and optimal dosing.12467

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for men with advanced or metastatic prostate cancer whose disease has gotten worse after their last treatment. Participants must be in generally good physical condition, have at least 3 months to live, and continue hormone therapy or have had both testicles removed.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity only.
Life expectancy is >= 3 months
I have been diagnosed with prostate adenocarcinoma.
See 4 more

Exclusion Criteria

I have not had a serious infection or needed antibiotics recently.
I have pain that is not well managed.
I have bone lesions that may break or fracture soon.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of GDC-1261 to evaluate safety and pharmacokinetics

8-12 weeks

Dose Expansion

Participants receive the recommended dose of GDC-1261 to further evaluate safety and preliminary activity

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GDC-1261

Trial Overview

The study is testing a new drug called GDC-1261 to see how safe it is, how the body processes it, and if it helps treat advanced prostate cancer. Researchers will also determine the best dose for future studies.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dose Escalation + ExpansionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

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6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39317633/

Final Analysis from the Randomized Phase 3 MAGNITUDE ...

Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene Alterations: Final Analysis from ...

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