Zanzalitinib for Prostate Cancer

PB
Overseen ByPedro Barata, MD, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Zanzalintinib, for effectiveness in treating metastatic castrate-resistant prostate cancer (mCRPC), a type of prostate cancer that has spread and does not respond to standard hormone treatments. The trial aims to determine if Zanzalintinib can effectively treat this advanced cancer. Individuals with this form of prostate cancer, who have noticeable cancer spread in soft tissues or organs and have tried other specific treatments, might be suitable candidates for this study. As a Phase 2 trial, the research measures how well Zanzalintinib works in an initial, smaller group of participants, offering a chance to contribute to the development of a potentially effective treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications like small molecule kinase inhibitors and some anticoagulants need to be stopped before starting the trial. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that Zanzalintinib is likely to be safe for humans?

Research has shown that Zanzalintinib is generally well-tolerated in patients with advanced prostate cancer that no longer responds to hormone therapy. Some studies have assessed its safety and effectiveness in patients who have already tried other treatments. These studies found that while some patients experienced side effects, they were mostly manageable. Common side effects included tiredness and nausea, typical of many cancer treatments. Importantly, available studies have reported no severe or unexpected problems directly linked to Zanzalintinib. This suggests that Zanzalintinib is relatively safe for people with this type of prostate cancer, though individual experiences may vary.12345

Why do researchers think this study treatment might be promising?

Zanzalitinib is unique because it targets metastatic castration-resistant prostate cancer (mCRPC) differently than standard treatments like androgen deprivation therapy (ADT) and chemotherapy. Unlike these options, Zanzalitinib offers a novel mechanism of action that directly addresses the cancer cells' resistance to traditional hormone treatments. Researchers are excited about Zanzalitinib because it has the potential to keep patients progression-free for longer periods, offering a new hope for those who haven't responded well to existing therapies.

What evidence suggests that Zanzalintinib might be an effective treatment for prostate cancer?

Research has shown that Zanzalitinib holds promise for treating metastatic castrate-resistant prostate cancer (mCRPC). This cancer remains challenging because it continues to grow despite hormone therapy. Early findings suggest that Zanzalitinib might help manage the disease, particularly when it has spread to other areas of the body. Although researchers are still gathering specific data on Zanzalitinib, there is hope for improved outcomes in patients who haven't responded well to other treatments. The treatment targets cancer cells more effectively, potentially leading to better survival rates. Further studies are necessary to confirm these encouraging early results.678910

Who Is on the Research Team?

PB

Pedro Barata, MD, MSc

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with metastatic castration-resistant prostate cancer (mCRPC) whose cancer has spread to soft tissue or organs and who have already tried other treatments that no longer work.

Inclusion Criteria

I am able to care for myself and do some daily activities.
I am 18 years old or older.
I agree to use two effective birth control methods during and after the study as required.
See 6 more

Exclusion Criteria

Corrected QT interval > 480 ms within 14 days before first dose by triplicate ECG
History of psychiatric illness interfering with compliance or consent
Inability to swallow tablets
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zanzalitinib for metastatic castration-resistant prostate cancer. Treatment cycles are 28 days each.

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Zanzalintinib

Trial Overview

The study is testing a new drug called Zanzalintinib to see if it helps treat mCRPC. Participants will take the drug for up to 24 months as long as they benefit from it.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ZanzalintiniibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pedro Barata, MD, MSc

Lead Sponsor

Trials
1
Recruited
10+

Citations

Phase II Trial of Zanzalitinib in Patients With Metastatic ...

The purpose of this study is to find out if Zanzalintinib is an effective treatment for participants with mCRPC with soft tissue or visceral ...

Real-World Outcomes in First-Line Treatment of Metastatic ...

Metastatic prostate cancer has a 30% 5-year survival rate despite recent therapeutic advances. There is a need to improve the clinical ...

Metastatic Castration-Resistant Prostate Cancer (mCRPC) ...

In 2023, the United States held the highest mCRPC market share in the 7MM, contributing to ~64%, of the total metastatic castrate resistant prostate cancer ...

Treatment Landscape of mCRPC "Presentation" - Matthew ...

We're going to go over the treatment landscape of metastatic castration-resistant prostate cancer. Obviously, this is a massive topic. We won't ...

Overview of the Metastatic Castration-Resistant Prostate ...

Expert oncologists briefly review the current treatment paradigm of metastatic castration-resistant prostate cancer (mCRPC).

PRO-XL: A phase II study of zanzalintinib (XL092) in ...

PRO-XL: A phase II study of zanzalintinib (XL092) in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on ...

Zanzalintinib Efficacy Post Pluvicto® in Chemotherapy ...

Metastatic Castrate Resistant Prostate Cancer (mCRPC) with histologically/cytologically confirmed adenocarcinoma without small cell histology.

MCRPC (Metastatic Castration-resistant Prostate Cancer)

MCRPC (Metastatic Castration-resistant Prostate Cancer) Phase Trials for Zanzalintinib (DB17525). Back to MCRPC (Metastatic Castration-resistant Prostate Cancer).

PRO-XL: evaluating zanzalintinib in mCRPC after 177Lu ...

This investigator initiated clinical trial of zanel niip in patients with metastatic castration resistant prostate cancer.

Metastatic Castration-Resistant Prostate Cancer clinical ...

The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation ...