Status:
RECRUITING
A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C (GCC)
Lead Sponsor:
Peking University
Collaborating Sponsors:
Nanjing Legend Biotech Co.
Conditions:
Advanced Gastrointestinal Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a phase 1, single-arm, open-label, dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C (GCC).
Detailed Description
This is a phase 1, single-arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR- G08 in s...
Eligibility Criteria
Inclusion
- Voluntary agreement to provide written informed consent.
- Histologically confirmed metastatic colorectal cancers and other advanced gastrointestinal cancers (esophageal cancer, gastric cancer, pancreatic cancer, and small bowel cancer).
- Aged 18 to 70 years, either sex.
- GCC immunohistochemistry (IHC) staining is positive.
- At least one measurable tumor lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival ≥ 3 months.
- Clinical laboratory values meet screening visit criteria.
Exclusion
- Previous CAR-T cell, T cell receptor-engineered (TCR) T cell, or therapeutic tumor vaccination treatment within the past 6 months; and the corresponding CAR-T, TCR-T cells can still be detected.
- Ever received any treatment targeting GCC.
- Prior antitumor therapy with insufficient washout period.
- Brain metastases.
- Pregnant or lactating women.
- Hepatitis C virus (HCV) antibody-positive or human immunodeficiency virus (HIV) antibody-positive, active syphilis, Epstein-Barr virus (EBV) infected.
- Severe underlying disease.
- Presence of other serious pre-existing medical conditions that may limit patient participation in the study.Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
- Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
Key Trial Info
Start Date :
December 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06197178
Start Date
December 28 2023
End Date
March 1 2028
Last Update
December 30 2024
Active Locations (2)
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1
Beijing Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100142
2
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200