Spots Global Cancer Trial Database for A Study of RC118 Plus Toripalimab in Patients With Locally Advanced Unresectable or Metastatic Solid Tumors

Study Description

Brief Summary: In Phase I, This study will explore the tolerability and safety of RC118 in combination with toripalimab for treatment of patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression, and determine the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); In Phase IIa, to explore the clinical effectiveness and safety of long-term use of RC118 in combination with toripalimab at RP2D doses for patients with different tumor types.

Detailed Description: this study is an open, single arm, multi-center Phase I /IIa clinical study. In the phase I, patients with locally advanced unresectable or metastatic malignant solid tumors (gastric cancer, esophageal cancer, gastroesophageal junction cancer, pancreatic cancer, ovarian cancer, cholangiocarcinoma, etc.) that are positive for Claudin 18.2(positive membrane staining observed in any tumor cells) will be included. in Phase I dose escalation phase, 4 dose groups of RC118 will be preset：1.0 mg/kg、1.5 mg/kg、2.0 mg/kg and 2.5 mg/kg, and toripalimab is fixed dose of 3.0mg/mg; In phase IIa cohort expansion phase, with reference to the results of the phase I study, subjects were grouped according to different tumor types, there are at least 20 subjects in each group, initially considering the inclusion of Claudin 18.2 positive (a clear cut-off value will be defined based on the results of Phase I) locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction cancer, and other solid tumors (The specific tumor types and groups will be further adjusted based on the results of the phase I study).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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