Trastuzumab for Healthy Subjects

Recruiting at 3 trial locations

Overseen By Reference Study ID Number: GP44770 https://forpatients.roche.com/

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Must not be taking: Anticancer drugs

Disqualifiers: Cardiac conditions, Diabetes, Hypertension, Allergies, TB, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

312 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how trastuzumab, a type of targeted therapy, behaves in the body when administered through different devices. The goal is to determine if these devices deliver the medication similarly and safely. The trial seeks healthy volunteers without significant medical issues who meet specific health criteria, such as having a healthy heart and no drug sensitivities. Participants will receive a single dose of the medication through one of the devices. Those who are generally healthy and wish to contribute to medical research may find this a suitable opportunity. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that trastuzumab, when injected under the skin, is generally well-tolerated. Studies have found this method to be as safe as the traditional intravenous administration. In one study, patients experienced side effects like redness or swelling at the injection site, but these were usually mild and did not cause serious problems. Additionally, the FDA has already approved trastuzumab for other uses, which adds confidence in its safety. Although this trial is in its early stages and tests different administration methods, monitoring the body's response remains important. Overall, existing evidence suggests that trastuzumab is safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Trastuzumab is unique because it explores new ways to deliver treatment that could enhance convenience and effectiveness. Unlike traditional intravenous methods, this study examines subcutaneous (SC) delivery using innovative devices like OBDS (on-body delivery systems) or HHS/SP (handheld syringe/safety pen). These delivery methods could make administration quicker and more comfortable for patients, potentially improving adherence to treatment and overall outcomes. Researchers are excited about these advancements because they may lead to more accessible and patient-friendly cancer therapies.

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

This trial will compare two formulations of trastuzumab administered subcutaneously. Studies have shown that trastuzumab significantly benefits people with HER2-positive breast cancer. It effectively reduces the risk of cancer recurrence and extends patient survival. Since 2006, trastuzumab has been a common treatment for this type of cancer due to its proven benefits. It is known for improving survival rates and reducing recurrence risk. However, some patients might experience heart issues, making regular check-ups during treatment important. Overall, trastuzumab remains a reliable option for treating HER2-positive breast cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy male participants who have not used drugs, are within a BMI range of 18 to 38 kg/m2 with body weight ≤100 kg, do not have hepatitis B/C or HIV, have normal heart function (LVEF ≥55%), and test negative for latent TB. Participants must agree to use contraception.

Inclusion Criteria

My BMI is between 18 and 38, and I weigh 100 kg or less.

I agree to use birth control and not donate sperm.

I tested negative for latent TB with the QuantiFERON® test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single SC dose of trastuzumab via different delivery platforms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Trastuzumab

Trial Overview The study is testing the bioequivalence of Trastuzumab when delivered through different methods: a handheld syringe/syringe pump with an infusion set and an on-body delivery system. It aims to see if both methods deliver the drug effectively in the same way.

How Is the Trial Designed?

Group I: Part 2 Experimental Treatment 1 Intervention

Participants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS.

Group II: Part 1 Experimental Treatment 1 Intervention

Participants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS.

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7051800/

Effectiveness of Trastuzumab for Human Epidermal Growth ... Trastuzumab has shown an overall survival (OS) benefit in patients with human epidermal growth factor receptor 2 (HER2)–positive breast cancer (BC), in both ...

2. herceptin.com herceptin.com/hcp/adjuvant-breast-cancer/efficacy/clinical-results.html

Herceptin Clinical Trial Results HERCEPTIN HYLECTA administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving HERCEPTIN ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(19)30650-6/fulltext

6 versus 12 months of adjuvant trastuzumab for HER2- ... Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breast cancer. The standard treatment duration is 12 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2059702925011998

Outcomes with trastuzumab deruxtecan by biomarker ... In conclusion, in a large real-world database, we found favorable outcomes with T-DXd for the treatment of MBC, although with worse outcomes than those observed ...

5. nature.com nature.com/articles/s41598-023-34429-9

Real world evidence of adjuvant trastuzumab in HER2 ... Adjuvant trastuzumab in HER2+ breast cancer reduces recurrence and mortality, and has been the standard treatment since 2006.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07214766

A Study to Assess the Bioequivalence of Trastuzumab Via ... This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38735220/

Results of an open-label, randomized, multicenter, phase ... Aim: To assess the safety and tolerability of subcutaneous (SC) trastuzumab (Herceptin) administered either with a single-use injection device (SID) or ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/761106Orig1s000MultidisciplineR.pdf

Multi-Discipline Review - accessdata.fda.gov and safety of subcutaneous (SC) trastuzumab with intravenous (IV) trastuzumab administered in women with HER2 positive with operable, locally advanced or ...

9. cancertreatmentreviews.com cancertreatmentreviews.com/article/S0305-7372(25)00096-9/fulltext

Systematic literature review of intravenous versus ... Overall survival, PK/PD, and overall response rate results were comparable between IV and SC administration. This SLR demonstrates that SC and ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11222001/

Subcutaneous Trastuzumab: An Observational Study of ... Conclusion: The research suggests that subcutaneous trastuzumab is comparable in effectiveness and safety to the intravenous administration.