China’s Innovent Biologics Inc. (HKG: 1801) and partner Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in a Phase I/II clinical study (NCT05383482) evaluating afuresertib combined with Tyvyt (sintilimab) plus chemotherapy in solid tumors resistant to PD-1/PD-L1 inhibitors.
Study Details
The multi-center, single-arm, open-label, dose-escalation study will assess the safety, tolerability, and antitumor activity of the combination. Primary endpoints include the recommended Phase II dose (RP2D) in Phase I and overall response rate (ORR) in Phase II. The trial targets five solid tumors: non-small cell lung cancer, gastric/gastroesophageal junction adenocarcinoma, esophageal cancer, cervical cancer, and endometrial cancer.
Drug Profiles
- Afuresertib: A highly selective AKT inhibitor licensed from Novartis in 2018, currently in five clinical trials for combination therapies in ovarian, prostate, breast cancers, and PD-1/PD-L1 resistant tumors.
- Tyvyt (sintilimab): Innovent’s PD-1 inhibitor approved for six indications in China, with four covered by the National Reimbursement Drug List (NRDL).-Fineline Info & Tech
