Safety and Efficacy of NK510 to Treat Gastric Cancer

Sponsor
Base Therapeutics (Shanghai) Co., Ltd.
Study ID
NCT06098898
Phase
EARLY_PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NK510 — DRUG
    NK510 will be administered through intravenous infusion.3 infusions on Day 0，Day 2 and day 3 for a cycle，for a total of two cycles.
  • Tislelizumab，atezolizumab or Trastuzumab — DRUG
    Administer according to the instructions.

Study Details

This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer.NK510 will be administered in combination with PD-1 blockade or monoclonal anti-HER2 antibody. Patients are required to undergo a biopsy for confirmation of tumor PD-L1 and HER2 expression and. The safety and efficacy of this treatment will be evaluated.

Key Dates

Start date
Nov 1, 2023
Status verified
Oct 2023
Primary completion
Nov 1, 2024
Completion
Nov 1, 2024

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (low-dose NK510 monotherapy)
    NK510 9×10\^9 NK cells/dose.
  • Experimental: Group B (low-dose NK510 combined mAbs)
    NK510 9×10\^9 NK cells/dose. PD-1 blockade or anti-HER2 mAbs.
  • Experimental: Group C (high-dose NK510 combined mAbs)
    NK510 12×10\^9 NK cells/dose. PD-1 blockade or anti-HER2 mAbs.

Primary Outcome Measure

Dose-Limiting Toxicity [ Time Frame: 6 weeks ]

Related Studies