SYS6041 / CSPC Pharma - LARVOL DELTA

A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer (clinicaltrials.gov) - P2 | N=171 | Recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • HRD

A Phase I/IIa Study of SYS6041 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=260 | Recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

First-in-human • New P1/2 trial • Breast Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer (clinicaltrials.gov) - P2 | N=171 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Platinum resistant • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • HRD

SYS6041, a next-generation Folate Receptor α-targeted antibody-drug conjugates for the treatment of FRα-expressing malignancies (AACR 2025) - "In a FRα moderate ovarian PDX model with Olaparib resistance, SYS6041 significantly inhibited tumor growth at 3 mg/kg, whereas the MTI-ADC showed no inhibitory effect at 6 mg/kg. In a GLP toxicity study in cynomolgus monkey, SYS6041 demonstrated an encouraging tolerability with an HNSTD of 50 mg/kg, and favorable PK and DAR stability, and presented a good tolerability profile with therapeutic window (TW)>66 (HNSTD/MED). In conclusion, the distinct mode of action along with the proprietary drug-linker platform resulted in an excellent in-vivo antitumor potency and safety, which supports the potential of SYS6041 as a novel therapeutic agent that may help address unmet needs in patients with moderate and low FRα expressing malignancies."

ADC • Endometrial Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

SYS6041 (ANTIBODY-DRUG CONJUGATE) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. (HKEXnews) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited (the 'Company', together with its subsidiaries, the 'Group') is pleased to announce that the Investigational New Drug (IND) application for SYS6041 (Antibody-Drug Conjugate) (the 'Product') developed by the Group has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States. The Product has also obtained approval from the National Medical Products Administration of the People’s Republic of China in January 2025 to conduct clinical trials in China."

IND • New trial • Solid Tumor