Patritumab Deruxtecan for Cancer

Recruiting at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Interstitial lung disease, Organ transplant, CNS metastases, others

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

Compensation: Varies

Number of Visits: 2

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory: * Hepatoblastoma is a common liver cancer in babies and very young children * RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment The study treatment HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of HER3-DXd in children and if they tolerate it * What happens to HER3-DXd in children's bodies over time * If children who receive HER3-DXd have the cancer get smaller or go away

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for children with specific types of cancer: hepatoblastoma (a liver cancer) or rhabdomyosarcoma (RMS, a muscle cancer), which have either returned after treatment or didn't respond to previous treatments. Participants must have tried at least one systemic treatment and not be eligible for standard options. They should also be recovered from any serious effects of past cancer therapies.

Inclusion Criteria

The main

I had hepatitis C but my viral load is now undetectable.

My cancer is either advanced Rhabdomyosarcoma or Hepatoblastoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

Participants receive patritumab deruxtecan to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose

3 weeks per cycle

1 visit per cycle (in-person)

Efficacy Evaluation

Participants continue to receive patritumab deruxtecan to evaluate the efficacy of the treatment

3 weeks per cycle, up to approximately 5 years

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Patritumab Deruxtecan

Trial Overview The study tests HER3-DXd, also known as MK-1022 or patritumab deruxtecan, an antibody-drug conjugate designed to target and destroy cancer cells in children. The aim is to assess its safety, how it's processed by the body over time, and its effectiveness in reducing or eliminating the targeted cancers.

Participant Groups

Group I: Patritumab Deruxtecan Experimental Treatment 1 Intervention

Participants receive patritumab deruxtecan via IV infusion on Day 1 of each 3-week cycle until discontinuation or progression.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD