ArticleCancer chemotherapy and pharmacology2026
A phase 1, open-label study evaluating the pharmacokinetics, safety, and tolerability of vepdegestrant in Chinese patients with ER+/HER2- advanced breast cancer.
Article in Cancer chemotherapy and pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05732428 (A PHASE 1, OPEN LABEL STUDY EVALUATING THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF ARV-471), which is not on this map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 1, open label study evaluating the pharmacokinetics, safety, and tolerability of arv-471 (pf-07850327) as a single agent in chinese participants with er+/her2- advanced breast cancer
Who cites it
1 citing paper in PubMed.
- Population Pharmacokinetics and Exposure-Response Analyses of Vepdegestrant, a First-in-Class PROteolysis-TArgeting Chimera Estrogen Receptor Degrader.Journal of clinical pharmacology · 2026Trial
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeVepdegestrant is an investigational, orally administered PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader being evaluated for the treatment of ER+/HER2- advanced breast cancer, with promising results in prior studies of Western and Japanese patients. Vepdegestrant had not been previously evaluated in Chinese patients.
methodsThis phase 1 study (NCT05732428) assessed pharmacokinetics (PK) of vepdegestrant and its epimer (ARV-473), and safety and preliminary efficacy of vepdegestrant monotherapy (200 mg once daily [QD] in 28-day cycles) in Chinese adults with ER+/HER2- advanced breast cancer who had received ≥ 1 prior line of endocrine therapy.
resultsNine female Chinese patients were treated (median age, 56.0 [range: 42.0-69.0] years; six received ≥ 3 prior anticancer therapies in the advanced setting). Geometric mean area under the plasma concentration-time curve over the dosing interval was 9575 ng*h/mL following a single dose and 18,340 ng*h/mL following multiple daily doses on day 15; maximum observed concentration of vepdegestrant was 633.2 ng/mL and 1035 ng/mL after single and multiple doses, respectively. Vepdegestrant was well tolerated. Most treatment-related adverse events (TRAEs) were grade 1 or 2. Two patients experienced grade 3 TRAEs; no patients discontinued due to AEs. Objective response and clinical benefit rates were 33.3% and 44.4%, respectively. Three patients had partial responses; all three subsequently had progressive disease at the final data cutoff.
conclusionsVepdegestrant (200 mg QD) demonstrated a PK profile comparable to previous studies, a well-tolerated safety profile, and signs of preliminary antitumor activity in heavily pretreated Chinese patients with ER+/HER2- advanced breast cancer. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID, NCT05732428.
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