KSHN001126 / Kashiv Biosci - LARVOL DELTA

SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of KSHN001126 in Healthy Post-Menopausal Females (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Shivanka Research, LLC

New P1 trial

Preclinical characterization of KSHN001126, a novel, differentiated and steroidal oral selective estrogen receptor degrader (SERD) (AACR 2023) - "Fulvestrant (FLV) (Faslodex®) is the only clinically approved steroidal SERD that requires painful intramuscular administration...Whereas Elacestrant demonstrated efficacy only in a subset of the population (ESR1 mutant) with poor gastrointestinal tolerability...Overall, KSHN001126 demonstrated dose-dependent efficacy (wild type and ESR1 mutation), confirming target engagement and mechanistic synergy (CDK4/6-Palbociclib and PI3K-Alpelisib). Furthermore, KSHN001126 demonstrated additive antitumor efficacy when combined with FLV, indicating a potential additional mechanism other than SERD."

Preclinical • Oncology • CDK4 • ER