Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Ad… (NCT05539430) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma
United States56 participantsStarted 2023-04-18
Plain-language summary
This is a Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects with Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent.
✓. Be a female or male ≥ 18 and ≤ 75 years old at the time of signing of the prescreening ICF.
✓. For Part A and Part B Cohort MR1 only:
✓. Subjects with histologically/cytologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the GC/GEJC/EC for which standard treatment is considered intolerable, unlikely to confer significant clinical benefit, is no longer effective, or subject is ineligible or declines standard therapy.
✓. Subjects must have received prior therapy as follows:
✓. Subjects with histologically/cytologically confirmed unresectable, locally advanced or metastatic PDAC for which standard treatment is considered intolerable, unlikely to confer significant clinical benefit, is no longer effective, or subject is ineligible or declines standard therapy.
✓. Subjects must have received prior therapy as follows:
✓. Subjects with histologically/cytologically confirmed metastatic GC/GEJC/EC with RECIST v1.1 SD or PR at the initial response evaluation during first-line SOC treatment.
Exclusion criteria
✕7. No investigational therapies in first-line therapy, unless the investigational product is discontinued prior to enrollment on this trial.
✕. Presence of CLDN18.2 positive tumors with staining intensity of ≥ 1+ in ≥ 50% of tumor cells by immunohistochemistry (IHC) (Performed during Prescreening).
What they're measuring
1
To characterize the safety and tolerability of LB1908 and determine the optimal dose or recommended dose for expansion (RDE)
Timeframe: 28 days
2
To further characterize the safety and tolerability of LB1908 with the RDE identified in the dose-escalation and determine the recommended Phase 2 dose (RP2D)