{"entity":{"id":"paper-nct05101096-int-j-clin-oncol-2024","kind":"paper","name":"Preliminary results from ASCENT-J02: a phase 1/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors","aka":[],"tldr":"Published report from the ASCENT-J02 trial registered as NCT05101096, in International journal of clinical oncology (2024), chosen as the most cited paper whose own text cites the registry id.","summary":"Background: Sacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate approved outside Japan for second-line and later metastatic triple-negative breast cancer (mTNBC), based on the ASCENT study (NCT02574455). We report SG safety and efficacy in an open-label, phase 1/2 bridging study in Japanese patients with advanced solid tumors (ASCENT-J02; NCT05101096; jRCT2031210346).\n\nMethods: Phase 1 was a standard 3 + 3 design. Patients received intravenous SG 6 mg/kg, escalating to 10 mg/kg, on Days 1 and 8 per 21-day cycle; primary endpoints were safety, incidence of dose-limiting toxicity/toxicities (DLTs), and determination of the recommended phase 2 dose (RP2D). In the multicohort phase 2 study, patients in the mTNBC cohort with previously treated disease received SG at the RP2D; primary endpoint was independent review committee (IRC)-assessed objective response rate (ORR; RECIST v1.1). Safety was a secondary endpoint.\n\nResults: In phase 1 (N = 15), one DLT (grade 3 elevated transaminases) occurred with SG 10 mg/kg; RP2D was SG 10 mg/kg regardless of UGT1A1 status. In phase 2, 36 patients with mTNBC received SG 10 mg/kg. At median follow-up of 6.1 months, IRC-assessed ORR was 25.0% (95% CI 12.1-42.2; P = 0.0077). Median progression-free survival was 5.6 months (95% CI 3.9-not reached [NR]); median overall survival was NR. No treatment-emergent adverse events led to discontinuation or death.\n\nConclusions: SG RP2D was established as 10 mg/kg in Japanese patients. SG showed efficacy in Japanese patients with previously treated mTNBC, a manageable safety profile, and no new safety signals, consistent with the previous ASCENT study.\n\nIndexed on Europe PMC as PubMed record 39302614 (DOI 10.1007/s10147-024-02589-x). Its abstract cites the registry id NCT05101096, which is how it was matched to this trial; no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"Int J Clin Oncol 2024","url":"https://doi.org/10.1007/s10147-024-02589-x"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/39302614/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/39302614"},{"label":"ClinicalTrials.gov NCT05101096","url":"https://clinicaltrials.gov/study/NCT05101096"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct05101096"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["international-journal-of-clinical-oncology"],"dependsOn":[],"notes":[],"journal":"International journal of clinical oncology","year":2024,"doi":"10.1007/s10147-024-02589-x","pmid":"39302614","authors":"Naito Y, Nakamura S, Kawaguchi-Sakita N, et al.","paperType":"observational","findings":[],"whatItMeans":"This is the paper Europe PMC returns for registry id NCT05101096 with the most citations, so it is the natural first reading for anyone following the ASCENT-J02 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.","caveats":["Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.","The abstract cites more than one registry id (NCT02574455, NCT05101096); it was kept because the trial's acronym appears in the title."]},"route":"/key-papers/paper-nct05101096-int-j-clin-oncol-2024/","neighbours":{"trial":[{"id":"nct05101096","kind":"trial","name":"Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors","route":"/trials/nct05101096/"}],"journal":[{"id":"international-journal-of-clinical-oncology","kind":"journal","name":"International journal of clinical oncology","route":"/journals/international-journal-of-clinical-oncology/"}]}}