ZN-A-1041 for Healthy Subjects

Overseen By Reference Study ID Number: GP46367 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: Anticoagulants, CYP3A inhibitors

Disqualifiers: Metabolic disorders, Hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how food and the drug rabeprazole, a proton pump inhibitor, affect the new ZN-A-1041 tablet in healthy individuals. Participants will help researchers determine if the tablet behaves differently when taken with food or rabeprazole. The study uses different sequences to compare results. It suits those in good health who can adhere to specific dietary rules and lifestyle restrictions during the trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new tablet.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking most medications before joining the trial. Prescription medications, over-the-counter drugs, and certain foods and beverages must be avoided for a specified period before the trial, unless the investigator approves otherwise.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rabeprazole is generally safe for use. Studies with healthy individuals indicate that rabeprazole does not significantly interact with other medications, allowing it to be taken alongside other drugs without causing problems.

However, like any medication, rabeprazole can cause side effects. Some individuals might experience an allergic reaction, particularly if they are also taking antibiotics. It is important to be aware of this and seek medical help if any unusual symptoms occur. Overall, rabeprazole is well-tolerated, meaning most people can take it without serious issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Rabeprazole is unique because it targets and suppresses stomach acid production more effectively than some older proton pump inhibitors (PPIs). Unlike treatments such as omeprazole or lansoprazole, rabeprazole can offer a faster onset of action, which can be beneficial for people needing quick relief from acid-related issues. Researchers are excited about rabeprazole because it may improve patient outcomes with fewer side effects, offering a more efficient and potentially safer option for managing gastric acid-related conditions.

What evidence suggests that this trial's treatments could be effective?

Research has shown that ZN-A-1041 could be a promising treatment for HER2-positive advanced solid tumors, including breast cancer that has spread to the brain. Earlier studies found that ZN-A-1041 effectively fights tumors, especially in patients who haven't used similar drugs before. Initial results showed that 50% of patients experienced tumor shrinkage. Designed to reach the brain, this treatment may be effective for brain tumors. Overall, ZN-A-1041 shows strong potential for treating certain cancers. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI of 18-32. Participants must have normal medical exams, ECGs, vital signs, and lab tests. They can't use drugs or alcohol, must test negative for hepatitis and HIV, agree to contraception or abstinence, not donate sperm during the study, be able to swallow tablets whole and eat a high-fat meal as required.

Inclusion Criteria

I am in good health with no significant medical issues.

My recent blood and urine tests are within normal ranges.

I agree to use birth control or remain abstinent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a four-period crossover study to evaluate the effect of food and rabeprazole on the pharmacokinetics of ZN-A-1041

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rabeprazole

Trial Overview

The study is testing how food and Rabeprazole affect the body's handling of two formulations of ZN-A-1041 in healthy people. It's an open-label crossover study where participants will try each treatment in different periods to compare effects.

How Is the Trial Designed?

Group I: Sequence 8 Experimental Treatment 2 Interventions

Group II: Sequence 7 Experimental Treatment 2 Interventions

Group III: Sequence 6 Experimental Treatment 2 Interventions

Group IV: Sequence 5 Experimental Treatment 2 Interventions

Group V: Sequence 4 Experimental Treatment 2 Interventions

Group VI: Sequence 3 Experimental Treatment 2 Interventions

Group VII: Sequence 2 Experimental Treatment 2 Interventions

Group VIII: Sequence 1 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05593094

NCT05593094 | A Phase 1 Trial of ZN-A-1041 Enteric ...

This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination ...

2.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT05593094

UCSF Solid Tumor Trial → ZN-A-1041 Enteric Capsules or ...

This study is composed of three parts designed to evaluate the safety and efficacy of ZN-A-1041 in participants with HER2-positive advanced solid tumors. Phase ...

3.

medically.gene.com

medically.gene.com/global/en/unrestricted/oncology/SABCS-2024/sabcs-2024-poster-ma-zn-1041-a-potential-best-in-class-.html

ZN-1041, a potential best-in-class BBB Penetrable HER2 ...

ZN-1041, a potential best-in-class BBB Penetrable HER2 Inhibitor, has high antitumor activity in patients with Breast Cancer with CNS Metastases.

4.

jhoponline.com

jhoponline.com/issue-archive/2023-issues/june-2023-vol-13-no-3/preclinical-and-early-clinical-data-show-promising-antitumor-activity-with-the-her2-inhibitor-zn-1041-in-patients-with-breast-cancer-and-brain-metastases

Preclinical and Early Clinical Data Show Promising ...

In the phase 1b portion of the trial, ZN-1041 monotherapy yielded an ORR and intracranial ORR of 50% in patients with TKI-naïve HER2-positive ...

5.

patlynk.com

patlynk.com/trial/NCT05593094

ZN-A-1041 Enteric Capsules for HER2-Positive Advanced ...

Study AimThis study evaluates the safety and effectiveness of ZN-A-1041 capsules, alone or in combination with other treatments, in people with advanced ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf

ACIPHEX®(rabeprazole sodium) Label - accessdata.fda.gov

Studies in healthy subjects have shown that rabeprazole does not have clinically significant interactions with other drugs metabolized by the CYP450 system, ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3982628/

An open-label, non-comparative, non-interventional, multi- ...

The aim of the study was to monitor the safety and efficacy of rabeprazole administered to patients with erosive or symptomatic non-erosive reflux disease.

8.

gps.mylwebhub.com

gps.mylwebhub.com/~/media/Global%20Product%20Catalog/US%20Product%20Catalog/Files/Safety%20Data%20Sheets/R/RABEPRAZOLE_NA_DR_TABS_MTR_NGHS_EN.ashx

Rabeprazole Sodium Delayed-Release Tablets

The intent of this safety data sheet (SDS) is to provide safety information for occupational handling of this product.

9.

mayoclinic.org

mayoclinic.org/drugs-supplements/rabeprazole-oral-route/description/drg-20066981

Rabeprazole (oral route) - Side effects & dosage

Rabeprazole may cause a serious type of allergic reaction when used in patients with conditions treated with antibiotics. Call your doctor right away if you or ...

10.

assets.hpra.ie

assets.hpra.ie/products/Human/17392/LicenseSPC_PA0408-089-001_07082012145321.pdf

Rabeprazole 10mg Gastro-resistant Tablets

Studies in healthy subjects have shown that rabeprazole sodium does not have clinically significant interactions with amoxicillin. Rabeprazole does not ...