Patritumab deruxtecan for children with relapsed or refractory hepatoblastoma or rhabdomyosarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 interventional trial gives HER3-DXd (patritumab deruxtecan), an antibody-drug conjugate that delivers chemotherapy to cells expressing the HER3 protein, to pediatric participants with relapsed or refractory hepatoblastoma or rhabdomyosarcoma. Part 1 is a safety lead-in to identify a tolerable dose and characterize pharmacokinetics, and Part 2 evaluates efficacy at the recommended phase 2 dose. Key outcomes include safety/tolerability, drug behavior in the body, and objective tumor response. The trial is sponsored by Merck with collaboration from Daiichi Sankyo and is conducted at multiple U.S. pediatric cancer centers.

Why it matters

Who can join: the full rules

The main inclusion criteria include but are not limited to the following:

* Has one of the following histologically confirmed advanced or metastatic solid tumors: Rhabdomyosarcoma (RMS), or Hepatoblastoma
* Has progressed after at least 1 prior systemic treatment for RMS or hepatoblastoma and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens)
* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have Grade ≤2 neuropathy are eligible. Participants with Grade ≤2 alopecia are also eligible
* Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
* Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

The main exclusion criteria include but are not limited to the following:

* Has a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD/pneumonitis, or suspected ILD/pneumonitis, or ILD that cannot be ruled out by imaging
* Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
* Has a history of solid organ transplant
* Has a history of allogeneic stem cell transplant
* Has clinically significant corneal disease
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis/leptomeningeal disease; participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks
* Has uncontrolled or significant cardiovascular disorder
* Has a history of clinically significant congenital cardiac syndrome
* Has a history of human immunodeficiency virus (HIV) infection
* Has a known additional malignancy that is progressing or has required active treatment within the past 1 year
* Has an active infection requiring systemic therapy
* Has concurrent active hepatitis B (HBsAg positive and/or detectable HBV deoxyribonucleic acid \[DNA\]) and HCV defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid \[RNA\]) infection
* Has not adequately recovered from major surgery or have ongoing surgical complications

Where it's running

• Childrens Hospital Los Angeles ( Site 3006)
  Los Angeles, California, United States Recruiting
• Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)
  Aurora, Colorado, United States Recruiting
• Yale New Haven Hospital ( Site 3012)
  New Haven, Connecticut, United States Recruiting
• Johns Hopkins All Children's Hospital ( Site 3025)
  St. Petersburg, Florida, United States Recruiting
• University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)
  Iowa City, Iowa, United States Recruiting
• Dana-Farber Cancer Institute ( Site 3013)
  Boston, Massachusetts, United States Recruiting

+14 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.