Study of Dalotuzumab Alone and With Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-062 AM1)

Inclusion criteria:

- Participants of age 3 to 17 years for Part 1 of the study and age 6 to 17 years for
Parts 2 and 3 of the study

- Histologic or cytologic diagnosis of a malignant solid tumor, including tumors of the
central nervous system and lymphoma, that have progressed despite standard therapy or
for which no effective standard therapy is known.

- Measurable or non-measurable disease for Parts 1 and 2; measurable disease for Part 3

- Parts 2 and 3: must be able to swallow tablets

- Performance Status: Lansky Play Scale ≥70 for children <10 years of age; Karnofsky
score ≥70 for children ≥10 to <16 years; or Eastern Cooperative Oncology Group (ECOG)
Status 0-2 for patients age 16 and older

- Adequate organ function

- For females of reproductive potential, a negative pregnancy test must be documented
within 72 hours of receiving the first dose of study medication

- Participants of reproductive potential must agree to use (or have their partner use)
adequate contraception throughout the study, starting with Visit 1 through 30 days
after the last dose of study drug

Exclusion criteria:

- Currently receiving any other investigational agents or using any investigational
devices

- Leukemia

- Previously received dalotuzumab or other IGF-1R inhibitors for Part 1

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to dalotuzumab or ridaforolimus

- Persistent acute toxicity from previous therapy ≥Grade 2 (excluding alopecia,
neuropathy, or hearing loss)

- Uncontrolled intercurrent illness despite adequate therapy

- Pregnant or breastfeeding

- For Parts 2 and 3: requirement for concurrent treatment with medications that are
inducers or inhibitors of cytochrome P450 (CYP3A)

- Poorly controlled Type 1 or 2 diabetes