ciletatug vedotin (RC118) / Rongchang Pharma, Biocytogen - LARVOL DELTA

RC118 (CLDN18.2-targeted ADC) combined with PD-1 blockade or RC148 (PD-1/VEGF bispecific antibody) for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (la/m G/GEJA) (ESMO 2025) - P1/2 | "RC118 plus toripalimab (Tor) or RC148 is expected to enhance antitumor activity. Conclusions RC118 plus either RC148 or Tor showed promising ORR and manageable safety in CLDN18.2-positive la/m G/GEJA. A trend toward improved PFS was observed with RC118 + RC148."

IO biomarker • Late-breaking abstract • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • PD-L1

First in human phase I/II trial of claudin 18.2 ADC RC118 in patients with advanced gastric/gastroesophageal junction cancer (ESMO 2024) - P1/2 | "RC118 exhibits promising efficacy with a manageable safety profile. The ongoing study aims to identify the optimal dose regimen. Also a combination study with toripalimab is in progress."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • HER-2

A Study of RC118 in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=135 | Recruiting | Sponsor: RemeGen Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Sep 2025

Metastases • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18

A Study of RC118 Plus Toripalimab in Patients With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=64 | Recruiting | Sponsor: RemeGen Co., Ltd.

Combination therapy • IO biomarker • Metastases • New P1/2 trial • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18

A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: RemeGen Co., Ltd. | Active, not recruiting ➔ Completed | N=33 ➔ 7 | Trial primary completion date: Apr 2023 ➔ Nov 2022

Enrollment change • Metastases • Trial completion • Trial primary completion date • Oncology • Solid Tumor • CLDN18

RemeGen's RC118 for Injection Targeting Claudin 18.2 in Patients with Gastric and Pancreatic Cancers Granted Two Orphan Drug Designations by U.S. FDA (PRNewswire) - "RemeGen Co., Ltd...announced on December 7, 2022, that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer."

Orphan drug • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=33 | Active, not recruiting | Sponsor: RemeGen Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor • CLDN18

A Study of RC118 in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=135 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18

A Study of RC118 in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2; N=135; Not yet recruiting; Sponsor: RemeGen Co., Ltd.

New P1/2 trial • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18 • MRI

A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours (clinicaltrials.gov) - P1; N=33; Recruiting; Sponsor: RemeGen Co., Ltd.; Trial completion date: Feb 2022 ➔ May 2023; Trial primary completion date: Dec 2021 ➔ Apr 2023

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • CLDN18

A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours (clinicaltrials.gov) - P1; N=33; Recruiting; Sponsor: RemeGen Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor • CLDN18