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Urothelial Carcinoma / Lung Neoplasms / EP0057 · Phase 1/2 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a terminated Phase 1/2 trial of EP0057 (nanoparticle camptothecin) plus olaparib in relapsed/refractory cancers, with small cell lung cancer as a named expansion cohort. No results are posted in this registry record; the study enrolled 45 participants but outcome data are not publicly available.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Urothelial Carcinoma, Urothelial Cancer, Lung Neoplasms, Small Cell Lung Cancer, Prostate Cancer; age from 18 Years. Intervention: 1/Phase I - EP0057 (formerly CRLX101) + Olaparib; 2/Phase II - EP0057 + Olaparib at Maximum Tolerated Dose/Re…. n = 45. 1 site: United States.
This is a terminated Phase 1/2 trial of EP0057 (nanoparticle camptothecin) plus olaparib in relapsed/refractory cancers, with small cell lung cancer as a named expansion cohort. No results are posted in this registry record; the study enrolled 45 participants but outcome data are not publicly available.
This is a registry record only; no results, efficacy data, or safety outcomes are reported.
No clinical impact can be assessed from this registry record, as no results are posted. The trial was terminated and the reason for termination is not stated in this document.
This is a Phase 1/2 trial registry record with no posted results; the study has been terminated and no efficacy or safety outcomes are reported in this document.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record, as no results are posted. The trial was terminated and the reason for termination is not stated in this document.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT02769962). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: TERMINATED. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 45 participants (ACTUAL). Conditions: Urothelial Carcinoma, Urothelial Cancer, Lung Neoplasms, Small Cell Lung Cancer, Prostate Cancer. Interventions: DRUG: EP0057; DRUG: olaparib; DIAGNOSTIC_TEST: CT scan; DIAGNOSTIC_TEST: CT chest, abdomen, and pelvis; DIAGNOSTIC_TEST: Bone scan; DIAGNOSTIC_TEST: ECG; DIAGNOSTIC_TEST: Echocardiogram; PROCEDURE: Biopsy. Primary outcome measures: Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of EP0057 (CLRX101) in Participants With Refractory Cancers. , First 28 days; Phase I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Olaparib in Participants With Refractory Cancers. , First 28 days; Number of Dose Limiting Toxicities (DLTs) During the First Cycle , First 28 days; Expansion: Progression Free Survival (PFS) Rate in the Combination of Olaparib Plus EP0057 (CLRX101) at 16 Weeks in Small Cell Lung Cancer (SCLC) Participants , 16 weeks; Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Urothelial Carcinoma , 8 weeks; Expansion: Overall Response Rate (Complete Response (CR) + Partial Response (PR) of EP0057 (CLRX101) Plus Olaparib in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) , 12 weeks. Brief 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.
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