Qilu Pharmaceutical Discloses First Clinical Data of PROTAC Drug QLH12016 Targeting Androgen Receptor in mCRPC
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Source: PharmaCube Info
Recently,Full Text of Regular Abstracts for ESMO 2025 CongressAnnouncement. At this conference, Qilu Pharmaceutical disclosed its PROTAC drug.QLH12016The first clinical data of the drug, which targets the androgen receptor (AR).
As of February 14, 2025, a total of 36 patients with metastatic castration-resistant prostate cancer (mCRPC) were enrolled to receive QLH12016 (100-1200mg, once daily).TreatmentAll patients had metastatic disease, with 28% of patients having visceral metastases (lung, 11.1%; liver, 2.8%). 69.4% of patients had ligand-binding domain wild-type.（LBD wt），30.6% of patients had LBD mutations (including L702H).
The results showed that inWithin the dose range of 100-1200mgNo dose-limiting toxicity (DLTs) was observed. Treatment-related adverse events (TRAEs) occurred in 33 patients (91.7%), with 14 experiencing grade 3 or higher TRAEs. The most common TRAEs were anemia (n=23, 63.9%), asthenia (n=17, 47.2%), and weight loss (n=15, 41.7%). NoGrade 3 and aboveGastrointestinal TractTRAEs。Grade 3 and aboveHematologyTRAEsUncommon (anemia, 5.6%; decreased neutrophil count, 2.8%).
In terms of efficacy, the entire population,600mg dose group (n=13) and 900mg (n=10)The median radiographic progression-free survival (rPFS) was 7.4 months, 9.0 months, and not yet reached, respectively.In summary, QLH12016 demonstrated promising efficacy regardless of LBD status.
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