A Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate the Safety, Feasibility, and Preliminary Efficacy of IMC002 in Patients With Claudin18.2-positive Advanced Digestive System Tumors

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures

• Age \> 18 and ≤70 years

• Patients with histologically or cytologically confirmed locally advanced/metastatic digestive system tumors including but not limited to advanced gastric cancer at least failed two lines of SOC, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer failed at least one line SOC;

• Must have CLDN18.2 positive tumor expression histologically as determined by IHC (defined as positive rate of tumor cells≥40% and staining intensity ≥2+ ) or a biopsy if archived tumor sample is not available; representative tumor samples (primary or metastatic, archived or newly collected) are expected to be obtained

• Expected survival time ≥12 weeks

• Measurable or evaluable disease per RECIST1.1

• ECOG performance status score of 0-1

• Adequate organ and bone marrow function. If any laboratory test results are abnormal with reference to the criteria below, a repeat test can be performed within 1 week. If the test results are still abnormal, the patient fails screening.

• Recovery to grade 0-1 from AEs related to prior anticancer therapy or to an acceptable level for inclusion/exclusion criteria except alopecia and vitiligo

• Female of childbearing age must undergo a serum pregnancy test with negative results at screening and infusion; Female of childbearing age or male patients whose sexual partners are females of childbearing age are willing to take medically approved high-efficiency contraceptive measures such as intrauterine devices or condoms from the time of signing the informed consent to 1 year after infusion (women of childbearing age include premenopausal women and women within 24 months of post menopause).

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
First Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
Renji Hospital, Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Contact Information
Primary
Jianming Xu, Pro.
jmxu2003@163.com
13910866712
Backup
Rongrui Liu, MD
liurongrui@hotmail.com
13911726595
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 18
Treatments
Experimental: IMC002 dose 1-3
IMC002 single infusion
Related Therapeutic Areas
Sponsors
Leads: Suzhou Immunofoco Biotechnology Co., Ltd

This content was sourced from clinicaltrials.gov