MedTrace Logo

The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors

NCT05964543 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-07-28

No results posted yet for this study

Summary

The main purpose of this study is to evaluate safety, tolerability and the efficacy of Q-1802 plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of Q-1802 and the immunogenicity profile of Q-1802 will be evaluated as well.

Conditions

  • Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

DRUG

Q-1802 Injection,Oxaliplatin Injection,Capecitabine

Q-1802：A dose Q-1802 will be administered intravenously Q2W. XELOX（oxaliplatin，capecitabin）: 21 days as a cycle Oxaliplatin will be administered 130mg/m2 as a 2-hour IV infusion,administer once on the first day, with 21 days as a cycle Capecitabine will be administered 1000mg/m2 orally twice daily (D1-D14),21ds is one cycle.

Sponsors & Collaborators

  • QureBio Ltd.

    lead INDUSTRY

Principal Investigators

  • Lin Shen, MD · Department of Medical Oncology, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2024-08-30
Completion
2025-08-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05964543 on ClinicalTrials.gov