Clinical Trials / Research Studies

Clinical Trials / Research Studies

Who can participate?

Inclusion Criteria:

• Parts A and B only:

• Participants must be less than or equal to (≤)18 years of age.

• Body weight greater than or equal to (≥)10 kilograms and body surface area (BSA) ≥0.5 -- Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies.

• For sites that are actively enrolling Parts B and C, participants with neuroblastoma who are eligible for Part C will be excluded from Part B unless approved by Lilly CRP/CRS.

• Part C only:

• Participants must be less than (<) 21 years of age.

• Participants have a BSA ≥0.3 m².

• Participants with first relapse/refractory neuroblastoma.

• All Parts

• Participants must have measurable or evaluable disease by RECIST v1.1 or RANO.

• A Lansky score ≥50 for participants <16 years of age or Karnofsky score ≥50 for participants ≥16 years of age.

• Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment.

• Able to swallow.

• Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug.

• Females of reproductive potential must have negative urine or serum pregnancy test at baseline (within 7 days prior to starting treatment).

• Female participants of reproductive potential must agree to use highly effective contraceptive precautions during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib. For other study drugs, highly effective contraceptive precautions (and avoiding sperm donation) must be used according to their label.

• Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment.

• Caregivers and participants willing to make themselves available for the duration of the trial.

Exclusion Criteria:

• Received allogenic bone marrow or solid organ transplant.

• Received live vaccination.

• Intolerability or hypersensitivity to any of the study treatments or its components.

• Diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers.

• Pregnant or breastfeeding.

• Active systemic infections or viral load.

• Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study.

• Parts A and C only: Have a bowel obstruction.

• Prior treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.

• Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor.

• Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma.

• Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device.

• Has received an experimental treatment in a clinical trial within the last 30 days or 5