SIM0348 / Simcere - LARVOL DELTA

Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=49 | Terminated | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | N=408 ➔ 49 | Trial completion date: Dec 2026 ➔ Apr 2026 | Active, not recruiting ➔ Terminated; Business decision

Enrollment change • First-in-human • Trial completion date • Trial termination • Oncology • Solid Tumor

First-in-human phase I study of the anti-TIGIT and PVRIG bispecific antibody as monotherapy or with sintilimab for advanced solid tumors (ESMO Asia 2025) - P1 | "SIM0348 plus sintilimab was well tolerated and demonstrated antitumor activity in participants with advanced NSCLC."

First-in-human • Metastases • Monotherapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TIGIT

Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=408 | Active, not recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | N=68 ➔ 408 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

LAE113, a novel TIGIT/PVRIG bispecific antibody for the treatment of cancer (SITC 2023) - "Conclusions LAE113 is an extremely potent TIGIT and PVRIG signaling blocker, outperforming existing competitors (Tiragolumab, COM701, SHR-2002 and SIM0348) in modulating T cell and NK cell functions, and exhibiting a favorable developability profile. It significantly enhanced T cell activity when combined with PD-L1 blockade. These findings suggest that LAE113 holds great promise as a candidate for cancer immunotherapy."

Oncology • CD8 • IFNG • NECTIN2 • PVR • TIGIT

Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Escalating Doses of SIM0348 as a Single Agent in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=68 | Not yet recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

Simcere Pharmaceuticals (02096): SIM0348 Injection (Humanized TIGIT/PVRIG Bispecific Antibody) was approved by the National Medical Products Administration for drug clinical trials [Google translation] (Zhitong Finance) - "Zhitong Finance APP News, Simcere Pharmaceutical (02096) announced that...the group's self-developed humanized TIGIT/PVRIG bispecific antibody SIM0348 injection has been issued by the State Drug Administration of China. The drug clinical trial approval notice, intended to be used to carry out clinical trials for the treatment of advanced malignant solid tumors."

New trial • Oncology • Solid Tumor