A Phase I Trial to Evaluate the Safety of IMC002 in Advanced Digestive System Tumors

NCT05946226 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-09-28

No results posted yet for this study

Summary

This is an open-label, multi-center, dose-escalation clinical study to evaluate the safety, feasibility, and preliminary efficacy of IMC002 in patients with CLDN18.2 positive digestive system tumors including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer.

Conditions

  • Advanced Digestive System Tumor

Interventions

BIOLOGICAL

IMC002 injection

three different IMC002 Doses will be escalated in "3+3" design

Sponsors & Collaborators

  • Suzhou Immunofoco Biotechnology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jianming Xu, Pro. · Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-09-07
Primary Completion
2025-12-01
Completion
2025-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT05946226 on ClinicalTrials.gov