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)
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
