SAR444200 / Sanofi - LARVOL DELTA

SAR444200 Demonstrates Safety, Signals of Clinical Activity in Advanced GPC3+ HCC, Other Solid Tumors (OncLive) - P1/2 | N=33 | NCT05450562 | Sponsor: Sanofi | "Findings presented at the 2025 ESMO Targeted Anticancer Therapies Congress showed that, among patients in Part 1A (n = 33), the total incidence of treatment-emergent cytokine release syndrome (CRS) was 9.1%. Three grade 3 or higher instances of CRS were reported as dose-limiting toxicities (DLTs) with 70 mg of SAR444200. Specifically, 2 CRS events were observed in patients treated at dose level 6A (DL6A; n = 3), and 1 occurred at dose level 7A (DL7A; n = 4) during lead-in dosing. These events were resolved completely with corrective treatment, including steroids and vasopressors, with or without tocilizumab (Actemra), and led to the permanent discontinuation of SAR444200....Furthermore, following treatment, 27.8% of patients (n = 18) exhibited at least a 50% decrease in levels of alpha-fetoprotein (AFP), a commonly used serological biomarker for HCC."

P1/2 data • Hepatocellular Cancer

Phase I/II, open-label, first-in-human study of the anti-GPC3 T cell engager SAR444200 in patients with advanced solid tumors: Updated safety and pharmacokinetic analysis (ESMO-TAT 2025) - P1/2 | "SAR444200 demonstrated a manageable safety profile at the DLs investigated in pts with GPC3+ advanced solid tumors."

Clinical • Metastases • P1/2 data • PK/PD data • Hepatocellular Cancer • Oncology • Solid Tumor • AFP • GPC3

Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=33 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | N=106 ➔ 33 | Trial completion date: Dec 2030 ➔ Dec 2025 | Trial primary completion date: Dec 2030 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • GPC3

Pharmacokinetics and biomarker analysis from a phase 1/2 open-label study of the anti-GPC3 T-cell engager SAR444200, in patients with advanced solid tumors. (ASCO 2024) - P1/2 | "Twenty-two patients (92%) reported treatment-related adverse events (TRAEs) of any grade, including three patients with a serious TRAE (2 events with hospitalization prolongation for a Grade 1 and 2 cytokine release syndrome [CRS] that recovered completely without and with Tocilizumab, respectively, 1 event with pneumonitis Grade 3). These results suggest that SAR444200 is tolerable at the tested dose levels in patients with GPC3+ advanced solid tumors. Dose escalation continues at this time."

Biomarker • Clinical • Metastases • P1/2 data • PK/PD data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Pneumonia • Solid Tumor • GPC3 • IFNG • IL6

Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=106 | Recruiting | Sponsor: Sanofi | Trial completion date: May 2030 ➔ Dec 2030 | Trial primary completion date: May 2030 ➔ Dec 2030

Metastases • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • GPC3

Phase I/II open-label study on an anti-GPC3 T cell engager, SAR444200, in patients with advanced solid tumors: Preliminary dose escalation results (ESMO 2023) - P1/2 | "Conclusions These preliminary results from the first two DLs suggest that SAR444200 is tolerable at the tested DLs in patients with advanced solid tumors. Dose escalation continues at this time."

Clinical • Metastases • P1/2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GPC3 • IFNG • IL6

Dose Escalation and Expansion Study of SAR444200 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=106 | Recruiting | Sponsor: Sanofi | Trial completion date: May 2029 ➔ May 2030 | Trial primary completion date: May 2029 ➔ May 2030

Metastases • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GPC3

Dose Escalation and Expansion Study of SAR444200 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=106 | Recruiting | Sponsor: Sanofi | Trial completion date: Feb 2028 ➔ May 2029 | Trial primary completion date: Feb 2028 ➔ May 2029

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GPC3

Dose Escalation and Expansion Study of SAR444200 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=106 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GPC3

Dose Escalation and Expansion Study of SAR444200 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=106 | Not yet recruiting | Sponsor: Sanofi

New P1/2 trial • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GPC3