Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

• INCLUSION CRITERIA: - Phase I
• Patients must have histologically or cytologically confirmed advanced solid tumor that is resistant or refractory to standard therapy.
• A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade =3,000/mcL
• absolute neutrophil count >=1, 500/mcL without growth factor support
• platelets >=100,000/mcL without growth factor support
• hemoglobin >=9 g/dL, and no blood transfusion within 4 weeks.

OR

• Hemoglobin >10 g/dL, and no blood transfusion within 2 weeks.
• total bilirubin = 51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal.

-The effects of EP0057 (formerly CRLX101) and olaparib on the developing human fetus are unknown. For this reason and because these agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Post-menopausal is defined as:

• Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
• Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for women under 50,
• radiation-induced oophorectomy with last menses >1 year ago,
• chemotherapy-induced menopause with >1 year interval since last menses,
• or surgical sterilization (bilateral oophorectomy or hysterectomy).
• Negative urine pregnancy test =18 years.
• Patients must have histologically or cytologically confirmed diagnosis of SCLC from a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
• Have received and progressed during or after a platinum-based standard chemotherapy regimen and/or an immune-checkpoint inhibitor
• Patients could have received any number of therapies for relapsed or progressive disease, including re-treatment with original frontline regimen. A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade =3,000/mcL
• absolute neutrophil count >=1, 500/mcL without growth factor support
• platelets >=100,000/mcL without growth factor support
• hemoglobin >=9 g/dL, and no blood transfusion within 4 weeks.

OR

• hemoglobin >10 g/dL, and no blood transfusion within 2 weeks.
• total bilirubin =51 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal.
• The effects of EP0057 and olaparib on the developing human fetus are unknown. For this reason and because these agents are known to be teratogenic, women of child-bearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries