eligibility_summary
Adults 18–75 with ECOG 0–1, ≥3‑month life expectancy, advanced pancreatic or colorectal cancer after ≥2‑line failure/intolerance, RECIST‑measurable disease, dual target‑positive biopsy (≤3y), adequate organ/bone marrow function, venous access, and contraception/negative pregnancy. Exclude active CNS mets, HIV/active HBV/HCV/syphilis, severe autoimmune/organ dysfunction, unstable CV/CNS disease, active infection, recent major surgery, recent systemic therapy or CAR‑T, severe allergies, anticoagulation, pregnancy/plans, noncompliance, other concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT06645301 (Early Phase 1), single-arm dose-escalation in refractory colorectal or pancreatic cancer. Intervention: BGT007, a biological cellular immunotherapy, given by IV infusion at 3.0×10^8 (Group A) or 6.0×10^8 cells (Group B), up to three monthly infusions if tolerated/beneficial. Mechanism/type: Cell-based therapy (exact cell type/engineering and antigen design not specified in the registry). Intended action is immune-mediated antitumor cytotoxicity, PK will be assessed. Targets/cells/pathways: Enrollment requires tumor positivity for two unspecified “target tests,” implying BGT007 is directed at dual tumor-associated targets, but the specific antigens and pathways are not disclosed. The therapy aims to leverage cellular immune effector pathways against gastrointestinal malignancies. Primary focus: safety/tolerability, secondary: PK and preliminary efficacy.