Trial NCT06941272
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
- Phase
- Phase 1/2
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Malignant Neoplasm
- Ages
- 0.08–17 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 weeksBrain metastases
* Has uncontrolled or significant cardiovascular disorderCardiac
* Has a history of clinically significant congenital cardiac syndrome
* Has a history of human immunodeficiency virus (HIV) infectionHIV
* Has a known additional malignancy that is progressing or has required active treatment within the past 1 yearPrior malignancy
* 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
Restrictions found (4)
- Brain metastasesConditionalexclusion
radiologically stable for at least 4 weeks
Show in the text - CardiacConditionalexclusionShow in the text
- HIVOutrightexclusionShow in the text
- Prior malignancyConditionalexclusion
within the past 1 year
Show in the text
Recruiting in Massachusetts
- Dana-Farber Cancer Institute ( Site 3013) · Boston, Suffolk County