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

NCT05946226 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: IMC002-RT01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of dose-limiting toxicity (DLTs) within 28 days after IMC002 infusion

  safety profile

  within 28 days

Secondary Outcomes (4)

• ORR after IMC002 infusion

  upto 96 weeks

• Incidences and severity of treatment-related adverse events (TRAEs)

  upto 96 weeks

• cytokine levels in the blood

  upto 96 weeks

• CAR-positive cell counts in peripheral blood

  upto 96 weeks

Other Outcomes (2)

• Immunogenicity parameters in peripheral blood

  upto 96 weeks

• long-term safety

  upto 96 weeks

Study Arms (1)

IMC002 dose 1-3

EXPERIMENTAL

IMC002 single infusion

Biological: IMC002 injection

Interventions

IMC002 injection BIOLOGICAL

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

Also known as: Autologous Claudin 18.2 specific CAR-T cell injection

IMC002 dose 1-3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Pregnant and lactating women
• Human immunodeficiency virus (HIV) antibody positive; acute or chronic active hepatitis B; acute or chronic active hepatitis C Hepatitis. Syphilis antibody positive; cytomegalovirus (CMV) infection; Epstein-Barr (EB) virus infection.
• Active or clinically poorly controlled serious infections
• Uncontrollable pleural effusion, pericardial effusion and ascites effusion existed before enrollment.
• Extensive or diffuse lung or liver metastases
• Oxygen saturation ≤95% without oxygen inhalation
• With other diseases that may limit their participation in this study, such as pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly controlled interstitial lung disease, or clinically significant abnormal lung function tests
• Known prior or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system (CNS) disease. Autoimmune diseases; CNS metastases or meningeal metastases with clinical symptoms, or other evidence that the patient's CNS or meningeal metastases have not been controlled, and are judged not suitable for the study by the investigator
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure \> 100 mmHg after standardized antihypertensive drug treatment); not well controlled diabetes mellitus \[fasting plasma glucose (FPG) ≥10.2mmol/L\].
• Presence of any of clinical cardiac symptoms or disorders
• Evidence of major coagulopathy or other significant bleeding risk
• Systemic steroids equivalent to \>15mg/day prednisone within 2 weeks before leukapheresis, except inhaled or topic steroids
• Requiring systemic therapy with corticosteroids or other immunosuppressive drugs during the treatment period. Presence of any active autoimmune disease, or history of autoimmune disease expect recur.
• Previous or concomitant other malignancies

Sponsors & Collaborators

• Suzhou Immunofoco Biotechnology Co., Ltd: lead

Study Sites (7)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Study Officials

• Jianming Xu, Pro.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianming Xu, Pro.

CONTACT

13910866712; jmxu2003@163.com

Rongrui Liu, MD

CONTACT

13911726595; liurongrui@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A classic 3+3 model will be used to dose escalation 3 doses will be used: 1×10\^8, 2.5×10\^8 and 5×10\^8 CAR-T cells/ patients

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 14, 2023
• Study Start: September 7, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)