A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer

Official Title

A Phase 3, Global, Multi-Centre, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Summary:

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Why is this study being done?

SPOTLIGHT is a new clinical study for adult patients who have any of:

• advanced unresectable gastric or GEJ cancer
• metastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.

For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.

Patients will be assigned to one of two groups by chance and given either:

• zolbetuximab with mFOLFOX6; or
• a placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.

The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS)

Secondary Outcome:

• Overall Survival (OS)
• Objective Response Rate (ORR)
• Duration Of Response (DOR)
• Safety and tolerability assessed by adverse events (AEs)
• Number of participants with laboratory assessments abnormalities and or adverse events
• Number of participants with vital signs abnormalities and or adverse events
• Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
• Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
• Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire
• HRQoL measured by the QLQ-OG25 questionnaire
• HRQoL measured by the Global Pain (GP) questionnaire
• HRQoL measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire
• PK of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough)
• Number of anti-drug antibody (ADA) Positive Participants

The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.

View this trial on ClinicalTrials.gov