SIM0235 / Simcere - LARVOL DELTA

SIM1811-03 (SIM0235), an anti-tumor necrosis factor receptor-2 (TNFR2) monoclonal antibody, in patients with advanced solid tumor and/or cutaneous T cell lymphomas (CTCL): Preliminary results from an on-going first-in-human phase I trial in China (ESMO 2023) - P1 | "The preliminary PK and PD results support every 3-week dosing at 40mg/kg as the recommended dose for expansion. The clinical development of SIM1811-03 in combination with immunotherapy is planned."

Clinical • Metastases • P1 data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD14 • TNFA • TNFRSF1B

A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors (clinicaltrials.gov) - P1 | N=255 | Recruiting | Sponsor: Jiangsu Simcere Biologics Co., Ltd | N=120 ➔ 255

Enrollment change • Metastases • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Skin Cancer • Solid Tumor • T Cell Non-Hodgkin Lymphoma

Simcere Zaiming Announces Clinical Collaboration to Evaluate SIM0235, a TNFR2 Monoclonal Antibody, in Combination with KEYTRUDA (pembrolizumab) in a Phase 1 Trial in Advanced Solid Tumors and Cutaneous T-cell Lymphoma (PRNewswire) - "Simcere Pharmaceutical Group Limited...announced today that Simcere Zaiming, an innovative oncology pharmaceutical company of Simcere has entered into a clinical collaboration agreement with MSD...to evaluate the combination of SIM0235, a potential first-in-class humanized anti-tumor necrosis factor receptor 2 (TNFR2) monoclonal antibody, and MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors and cutaneous T-cell lymphoma (CTCL). This is a Phase 1 trial (SIM1811-03-TNFR2-102) to evaluate the safety, efficacy, pharmacokinetic/pharmacodynamic characteristics and immunogenicity of SIM0235 monotherapy and SIM0235 in combination with KEYTRUDA in patients with advanced solid tumors and CTCL."

Clinical protocol • Licensing / partnership • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma

A Phase I Trial of SIM1811-03 in Subjects With Advanced Tumors (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Skin Cancer • Solid Tumor • T Cell Non-Hodgkin Lymphoma

A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

New P1 trial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • Skin Cancer • Solid Tumor • T Cell Non-Hodgkin Lymphoma