BY1298 / Chengdu Baiyu Pharma, Novartis - LARVOL DELTA

A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov) - P1/2 | N=123 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov) - P1/2 | N=123 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

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

A Phase L Study of By101298, an Oral DNA-PK Inhibitor, in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Oncology • Solid Tumor

A Phase Ib/II Study of BY101298 , an Oral DNA-PK Inhibitor, Combined with Radiotherapy in Patients with Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=60 | Terminated | Sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd. | Trial completion date: Jun 2026 ➔ Oct 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ Oct 2024; The sponsor adjusts the clinical development strategy.

Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Dosing, Treatment Pattern, and Safety of Finerenone Use in Routine Care: An Interim Analysis of the Prospective, Real-World, and Observational FINE-REAL Study (KIDNEY WEEK 2024) - P | "At baseline, ACEi/ARBs, SGLT2i, or GLP-1 RA were used by 1298 (71%), 946 (52%), and 522 (29%) pts, respectively. By UACR, the FINE-REAL study population has milder renal impairment than in other pivotal analyses such as FIDELIO DKD. Comedication of finerenone with ACEi/ARBs, SGLT2i, or GLP-1 RA is more optimized in the FINE-REAL study population than is typically observed in real-world practice. Pts with higher UACR received higher finerenone doses, and pts with no UACR available at baseline received lower doses."

Clinical • Real-world • Real-world evidence • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A Phase Ib/II Study of BY101298 , an Oral DNA-PK Inhibitor, Combined With Radiotherapy in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd.

New P1/2 trial • Oncology • Solid Tumor

A Phase l Study of By101298, an Oral DNA-PK Inhibitor, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd.

Combination therapy • Metastases • New P1 trial • Oncology • Solid Tumor

First-in-human phase 1 trial of the safety, tolerability, pharmacokinetics of BY101298: Initial report from dose escalation cohort. (ASCO 2024) - "In pts with advanced solid tumors, BY101298 exhibits a favorable safety profile and manageable toxicity. Vomiting was noted as a potential risk associated with BY101298. Further studies are imperative to elucidate the efficacy of BY101298 in combination with radiotherapy among pts with advanced solid tumors."

Clinical • P1 data • PK/PD data • Anemia • Hematological Disorders • Oncology • Solid Tumor