{"doi":"10.1093/oncolo/oyac100","title":"A Single-arm Phase II Study Combining NLG207, a Nanoparticle Camptothecin, with Enzalutamide in Advanced Metastatic Castration-resistant Prostate Cancer Post-Enzalutamide","abstract":"BACKGROUND: Despite the clinical efficacy of enzalutamide monotherapy in patients with advanced prostate cancer, therapeutic resistance and disease progression are inevitable. We proposed a study to evaluate NLG207, a nanoparticle-drug conjugate (NDC) of the potent topoisomerase I inhibitor camptothecin, in combination with enzalutamide, in patients with metastatic castration-resistant prostate cancer (mCRPC) following progression on enzalutamide. METHODS: This was a single-arm, optimal two-stage, phase II study to evaluate the efficacy of NLG207 in combination with enzalutamide in patients with mCRPC who received prior enzalutamide. A lead-in dose escalation evaluated the recommended phase 2 dose of NLG207 in combination with enzalutamide. Patients received NLG207 via IV infusion every 2 weeks and enzalutamide 160 mg orally once daily. RESULTS: Between March 2019 and June 2021, four patients were accrued to the lead-in dose escalation. Two of the four patients were evaluable and both experienced DLTs at the NLG207 12 mg/m2 dose level; one DLT was related to a dose delay for noninfective cystitis and myelosuppression, the other a grade 3 noninfective cystitis. Further evaluation of NLG207 in combination with enzalutamide was halted and the study was ultimately terminated. PSA declines from baseline were observed in two patients. CONCLUSION: NLG207 12 mg/m2 in combination with enzalutamide was not well tolerated in patients with mCRPC following several lines of the standard of care therapy. CLINICALTRIALS.GOV IDENTIFIER: NCT03531827.","journal":"The Oncologist","year":2022,"id":251798,"datarank":0.7895725096825397,"base_score":3.2188758248682006,"endowment":3.2188758248682006,"self_citation_contribution":0.48283137373023016,"citation_network_contribution":0.3067411359523095,"self_endowment_contribution":0.48283137373023016,"citer_contribution":0.3067411359523095,"corpus_percentile":null,"corpus_rank":null,"citation_count":24,"citer_count":24,"citers_with_citation_signal":19,"citers_with_endowment":19,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9568,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03531827"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":256069,"name":"Fatima Karzai","orcid":"0000-0002-3244-1332","position":1,"is_corresponding":false},{"id":256068,"name":"Marijo Bilušić","orcid":"0000-0003-1020-689X","position":2,"is_corresponding":false},{"id":256067,"name":"Lisa M. Cordes","orcid":"0000-0003-3833-4084","position":3,"is_corresponding":false},{"id":259971,"name":"Cindy H. Chau","orcid":"0000-0002-6928-3833","position":4,"is_corresponding":false},{"id":109199,"name":"Cody J. Peer","orcid":"0000-0001-9395-3473","position":5,"is_corresponding":false},{"id":370652,"name":"Susan Wróblewski","orcid":null,"position":6,"is_corresponding":false},{"id":370006,"name":"Alwin D. R. Huitema","orcid":"0000-0003-1939-4639","position":7,"is_corresponding":false},{"id":89422,"name":"Jan H.M. Schellens","orcid":"0000-0001-6832-1976","position":8,"is_corresponding":false},{"id":239942,"name":"James L. Gulley","orcid":"0000-0002-6569-2912","position":9,"is_corresponding":false},{"id":263633,"name":"William L. Dahut","orcid":"0000-0002-2766-9703","position":10,"is_corresponding":false},{"id":109200,"name":"William D. Figg","orcid":"0000-0003-2428-5613","position":11,"is_corresponding":false},{"id":256072,"name":"Ravi A. Madan","orcid":"0000-0001-5106-8636","position":12,"is_corresponding":false},{"id":370005,"name":"Keith T. Schmidt","orcid":"0009-0008-0285-0216","position":0,"is_corresponding":true}],"reference_count":28,"raw_metadata":null,"created_at":"2026-07-19T00:24:41.993282Z","pmid":"35640474","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}