All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Part A will follow the standard 3+3 dose escalation design, 3\~6 participants will be allocated to the first dose group of RC118, and receive a treatment of RC118-ADC (1.0mg/kg) and Toripalimab (3.0mg/kg) followed by 14 days of dose limited toxicity (DLT) observation period.

Part A will follow the standard 3+3 dose escalation design, 3\~6 participants will be allocated to the second dose group of RC118, and receive a treatment of RC118-ADC (1.5mg/kg) and Toripalimab (3.0mg/kg) followed by 14 days of dose limited toxicity (DLT) observation period.

Part A will follow the standard 3+3 dose escalation design, 3\~6 participants will be allocated to the Thrid dose group of RC118, and receive a treatment of RC118-ADC (2.0mg/kg) and Toripalimab (3.0mg/kg) followed by 14 days of dose limited toxicity (DLT) observation period.

Part A will follow the standard 3+3 dose escalation design, 3\~6 participants will be allocated to the last dose group of RC118, and receive a treatment of RC118-ADC (2.5mg/kg) and Toripalimab (3.0mg/kg) followed by 14 days of dose limited toxicity (DLT) observation period.

Part B-Arm 1 will include approximately 20 patients with gastric cancer (including gastric esophageal junction). This subject group will receive RC118-ADC and Toripalimab (3.0mg/kg) Day 1 of every 14-day cycle. The starting dose of RC118-ADC for expansion will be derived from the RP2D determined during Part A.

Part B-Arm 1 will include approximately 20 patients with pancreatic cancer and other solid tumors. This subject group will receive RC118-ADC and Toripalimab (3.0mg/kg) Day 1 of every 14-day cycle. The starting dose of RC118-ADC for expansion will be derived from the RP2D determined during Part A.

RC118 for injection is a novel antibody-drug conjugate, with a Claudin 18.2-targeting antibody and a microtube inhibitor

RC118

Toripalimab is a recombinant humanized anti-PD1 monoclonal antibody

Toripalimab

Jianming Fang, ph.D

Tianshu Liu, ph.D

liu.tianshu@zs-hospital.sh.cn Liu, ph.D

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.

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).

A Study of RC118 Plus Toripalimab in Patients With Locally Advanced Unresectable or Metastatic Solid Tumors

An Open, Multi-center Phase I/IIa Clinical Study of RC118 in Combination With Toripalimab for Treatment of Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors With Positive Expression of Claudin 18.2

In the DLT evaluation window (observation period 1-28 days after the first administration), according to the NCI-CTCAE v5.0 grading standard, the investigator or the sponsor believes that toxic reaction which are reasonably related to RC118 + Toripalimab treatment

The incidence and severity of adverse events (AE)

Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

Disease Control Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) or stable disease(SD)

Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Duration of response is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading

Overall survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the date of death.

RC118 pharmacokinetics: Area under the concentration time curve over the dosing interval.

RC118 pharmacokinetics: Maximum concentration of the drug (Cmax).

RC118 pharmacokinetics: Time to maximum concentration (Tmax).

RC118 pharmacokinetics: Elimination half-life (t1/2).

RC118 pharmacokinetics: Mean residence time (MRT).

RC118 pharmacokinetics: Apparent volume of distribution (Vd).

RC118 pharmacokinetics: Elimination rate constant (λz).

RC118 immunogenicity: Number of participants with anti-drug-antibody (ADA)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of RC118 Plus Toripalimab in Patients With Locally Advanced Unresectable or Metastatic Solid Tumors	NCT06038396	Advanced Solid ...	RC118 Toripalimab	18 Years - 75 Years	RemeGen Co., Ltd.
A Study of RC118 Plus Toripalimab in Patients With Locally Advanced Unresectable or Metastatic Solid Tumors	NCT06038396	Advanced Solid ...	RC118 Toripalimab	18 Years - 75 Years	RemeGen Co., Ltd.

Spots Global Cancer Trial Database for rc118

Every month we try and update this database with for rc118 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rc118

Every month we try and update this database with for rc118 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rc118 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.