JS107 / Shanghai Junshi Bioscience - LARVOL DELTA

Updated results from a phase I study of JS107, a claudin 18.2 (CLDN18.2)-targeting antibody-drug conjugate (ADC), in combination with toripalimab and chemotherapy as the first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) (ESMO Asia 2025) - P1 | "JS107 in combination with toripalimab and XELOX as the first-line treatment for CLDN18.2-high advanced G/GEJA showed encouraging efficacy with a manageable safety profile, warranting further evaluation in phase 3 trials."

Clinical • Combination therapy • Late-breaking abstract • Metastases • P1 data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2

A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=133 | Active, not recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Jul 2024 ➔ Dec 2027

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

Phase I dose-escalation and expansion study of JS107, a claudin 18.2 (CLDN18.2)-targeting antibody-drug conjugate (ADC), as monotherapy or in combination for patients (pts) with advanced solid tumors (AACR 2025) - P1 | "JS107 monotherapy or in combination with toripalimab and XELOX showed promising efficacy in pts with CLDN18.2-high advanced GC/GEJ with a manageable safety profile. The clinical benefit of CLDN18.2 ADC combination treatment was thus demonstrated for the first time. Further clinical development of JS107 in CLDN18.2+ advanced solid tumors is warranted."

ADC • Clinical • First-in-human • Metastases • Monotherapy • P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2

JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma. (clinicaltrials.gov) - P3 | N=560 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2

JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma. (clinicaltrials.gov) - P3 | N=560 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced Pancreatic Cancer (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | N=106 ➔ 8 | Not yet recruiting ➔ Terminated | Trial primary completion date: Sep 2024 ➔ Jan 2025; Company research and development strategy adjustment

Enrollment change • Trial primary completion date • Trial termination • Oncology • Pancreatic Cancer • Solid Tumor

A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced Pancreatic Cancer (clinicaltrials.gov) - P1 | N=106 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=118 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P1 trial • Oncology • Solid Tumor