RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD) (PAYLOAD)

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) with all standard treatment options having been exhausted or declined.
• Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening.
• Measurable disease per RECIST v1.1 by radiographic techniques
• Acceptable liver function, serum creatinine and hematological status
• Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001.
• Subjects with brain metastases are eligible

Exclusion Criteria:

• Concurrent anticancer therapy; however, radiotherapy is allowed
• Any history of hypersensitivity to irinotecan
• Cholangitis that required treatment or intervention within 4 weeks of study enrollment
• Bilirubin > 2.0 mg/dL
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study
• If female, subject is pregnant and/or breastfeeding.
• UGT1A1*28 homozygote or heterozygote
• BMI >35