At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed advanced solid tumor (Phase I) or specific cancer type (SCLC, urothelial carcinoma, mCRPC) with progressive/refractory disease
- ✓Phase II SCLC: prior platinum-based chemotherapy and/or immune-checkpoint inhibitor with documented progression
- ✓Urothelial cohort: prior platinum-based chemotherapy and/or immune-checkpoint inhibitor with progressive disease
- ✓mCRPC cohort: prior enzalutamide and/or abiraterone (or docetaxel + ADT in select cases) with documented castrate-resistant progression
- ✕Patients requiring enzyme-inducing antiepileptic drugs (carbamazepine, phenytoin, phenobarbital) within 14 days before first dose and during study
- ✕Hemoglobin <9 g/dL with recent transfusion (within 4 weeks), or <10 g/dL with transfusion within 2 weeks
- ✕Total bilirubin >1.5× ULN (unless Gilbert's Disease)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in Patients With Relapsed/Refractory Small Cell Lung, Bladder and Prostate Cancers
In Brief
A Phase 1 clinical trial evaluating EP0057, olaparib, and 6 other interventions for Urothelial Carcinoma and 4 related conditions. Completed, enrolled 45 participants across 1 site.
Signals
Detailed Summary
Background: EP0057 (formerly CRLX101) consists of a sugar molecule cyclodextrin linked to a chemotherapy drug called camptothecin. The combined molecule or "nanoparticle drug conjugate" travels through the blood. Once inside cancer cells, the chemotherapy drug is released from the molecule. Olaparib is a drug that may stop cancer cells from repairing the deoxyribonucleic acid (DNA) damage caused by chemotherapy. Researchers want to see how safe it is to give EP0057 and olaparib together and to see how well the combination treats a specific type of lung cancer called small cell lung cancer (SCLC). Objectives: To test the safety and maximum dose of EP0057 and olaparib together. To test how well they treat small cell lung cancer. Eligibility: Adults 18 and older with small cell lung cancer. Design: Participants will be screened with standard cancer care tests. Participants will get the 2 study drugs in 28-day cycles. EP0057 will be given every 2 weeks, through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a day most days. Participants will keep a pill diary. For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits. At study visits, participants may have: * Blood and hair samples taken * History and Physical exam * Questions about health and side effects * Pregnancy test * Optional tumor biopsy where a piece of tumor is removed by needle after numbing the skin. * Computed tomography (CT) scan * Injection of EP0057 (twice per cycle) * Olaparib prescription Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will have a physical exam and blood tests. They may have a tumor biopsy. The study team will call the patient every 3 months for follow up after completing the study treatment.
Study Details
Timeline
Arms & Interventions
EP0057 + olaparib
EP0057 (formerly CRLX101) + olaparib at maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)
Interventions
EP0057 (formerly CRLX101) intravenous (IV) every (Q) 2weeks Day 1 and Day 15, administered in 28-day cycles, until disease progression or development of intolerable side effects. Plus olaparib (by mouth (PO) days 3-13\* and days 17-26\*) administered in 28-day cycles, until disease progression or development of intolerable side effects. Phase (P)1: Dose Escalation P2: recommended phase 2 dose (RP2D). (\* On days 13 and 26, only one dose of olaparib will be administered in the morning)
Olaparib (by mouth (PO) days 3-13\* and days 17-26\* administered in 28-day cycles, until disease progression or development of intolerable side effects Plus EP0057 (formerly CRLX101) (intravenous (IV) every (Q) 2 weeks, Day 1 and Day 15) administered in 28-day cycles, until disease progression or development of intolerable side effects. Phase (P)1: Dose Escalation P2: recommended phase 2 dose (RP2D). (\* On days 13 and 26, only one dose of olaparib will be administered in the morning).
Screening and baseline.
Metastatic castration-resistant prostate cancer (mCRPC) participants only at screening, baseline, cycle 2 Day 1, and end of treatment/disease progression.
Metastatic castration-resistant prostate cancer (mCRPC) participants only at screening, baseline, cycle 2 Day 1, and end of treatment/disease progression.
Screening, baseline, Day 1, Day 15 and cycle 2, Day 1.
At screening.
Baseline Day 4 and end of treatment/disease progression.