A Study of Galunisertib on the Immune System in Participants With Cancer

Inclusion Criteria:

- Have a confirmed diagnosis of advanced, refractory solid tumors and tumor progression
or treatment intolerance to at least 1 prior therapy.

- Have measurable disease that is amenable to a radiographic or ultrasound-guided
biopsy or may be biopsied in the office without radiologic guidance.

- Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG)
scale.

- Have discontinued all disease-modifying therapy for the primary cancer for 28 days
prior to initiation of study treatment.

- Hepatic: bilirubin ≤1.5 times upper limits of normal (ULN), alanine aminotransferase
(ALT) and aspartate transaminase (AST) ≤3.0 times ULN. For participants with tumor
involvement of the liver, AST and ALT equaling

≤5.0 times ULN are acceptable. Alkaline phosphatase ≤5.0 times ULN for participants
with tumor involvement of the bone is acceptable.

- Have adequate renal function, defined as serum creatinine levels ≤2.0 ULN or
calculated creatinine clearance >45 mL/min.

- Male and female participants with reproductive potential must use an approved
contraceptive method, if appropriate (for example, intrauterine device, birth control
pills, or barrier device) during and for 6 months after discontinuation of study
treatment.

- Women of childbearing potential must have a negative beta-human chorionic
gonadotropin pregnancy test documented within 7 days prior to treatment. Have given
written informed consent prior to any study-specific procedures.

- Are willing and able to comply with study procedures and instructions, including
completion of diaries.

- Must have received at least 1 prior approved immunotherapy or chemotherapy; however,
not within 28 days of the initial dose of study drug. May have received prior
radiotherapy for their malignancy.

- May have received treatment with an investigational product.

Exclusion Criteria:

- Are enrolled in any other type of medical research judged not to be scientifically or
medically compatible with this study within 28 days of the initial dose of study
drug.

- Have moderate or severe cardiac disease:

- Have the presence of cardiac disease, including a myocardial infarction within 6
months prior to study entry, unstable angina pectoris, New York Heart
Association Class III/IV congestive heart failure, or uncontrolled hypertension.

- Have documented major electrocardiogram (ECG) abnormalities (not responding to
medical treatments) at the investigator's discretion (for example, symptomatic
or sustained atrial or ventricular arrhythmias, second- or third-degree
atrioventricular block, complete bundle branch block, ventricular hypertrophy,
or recent myocardial infarction).

- Have major abnormalities documented by echocardiography (ECHO) with Doppler (for
example, moderate or severe heart valve function defect and/or left ventricular
ejection fraction <50%, evaluation based on the institutional lower limit of
normal).

- Have predisposing conditions that are consistent with development of aneurysms
of the ascending aorta or aortic stress (for example, family history of
aneurysms, Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the
large vessels of the heart documented by computed tomography (CT) scan with
contrast).

- Are women who are pregnant or lactating.

- Have a serious concomitant systemic disorder (for example, active infection including
human immunodeficiency virus [HIV], hepatitis C virus [HCV], hepatitis B virus [HBV]
[ie, positive hepatitis B surface antigen [+HBsAg]]), or an autoimmune disease.

- Have a second primary malignancy or any history in any time frame of a prior
malignancy.

- Are unwilling or unable to participate in, or do not have tissue adequate for
participation in the biomarker analyses in the study.