A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Purpose
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
Condition
- Malignant Neoplasm
Eligibility
- Eligible Ages
- Between 1 Month and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 - 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 (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis that cannot be ruled out by standard diagnostic assessments - 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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Patritumab Deruxtecan |
Participants receive patritumab deruxtecan via IV infusion on Day 1 of each 3-week cycle until discontinuation or progression. |
|
Recruiting Locations
Aurora 5412347, Colorado 5417618 80045
Study Coordinator
720-777-1234
Iowa City 4862034, Iowa 4862182 52242
Study Coordinator
319-356-2296
Grand Rapids 4994358, Michigan 5001836 49503
Study Coordinator
616-486-0746
Kansas City 4393217, Missouri 4398678 64108
Study Coordinator
816-302-6808
New Brunswick 5101717, New Jersey 5101760 08901
Study Coordinator
732-235-2465
Valhalla 5142090, New York 5128638 10595
Study Coordinator
914-614-4270
Fargo 5059163, North Dakota 5690763 58122
Study Coordinator
701-234-2000
Philadelphia 4560349, Pennsylvania 6254927 19104
Study Coordinator
267-425-5544
Sioux Falls 5231851, South Dakota 5769223 57117
Study Coordinator
605-312-1000
Houston 4699066, Texas 4736286 77030
Study Coordinator
713-792-5410
Salt Lake City 5780993, Utah 5549030 84113
Study Coordinator
801-662-4700
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
Detailed Description
This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2).