QLH12016 / Qilu Pharma - LARVOL DELTA

Phase I study of QLH12016, an androgen receptor (AR) PROTAC degrader in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC): safety, tolerability, and antitumor activity (ESMO 2025) - P1 | "Conclusions QLH12016 was safe and well tolerated with favourable gastrointestinal and hematological safety profiles, supporting it as a potential treatment option for advanced prostate cancer as monotherapy and in combination therapies. Promising clinical activity in mCRPC was observed with QLH12016, regardless of the LBD status, warranting further development in additional clinical trials."

Clinical • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer (clinicaltrials.gov) - P1/2 | N=212 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of QLH12016 in Combination With Novel Hormonal Agent in Subjects With Advanced Prostate Cancer (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Trial of QLH12016 in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=108 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor