A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors

Prior treatment

• Prior treatment with any CLDN18.2 target agents
• Concurrent malignancy within 5 years prior to entry except adequately treated certain types of cancer

Other illness

• Allergy or sensitivity to TST001 or known allergies to comparable drugs
• Documented history of multiple other allergies requiring interventions
• Active and clinically significant infections, known uncontrolled infections with hepatitis B, hepatitis C, known human immunodeficiency virus with acquired immunodeficiency syndrome related illness
• Any condition that the investigator or primary physician believes may not be appropriate for participating in the study.
  • Other protocol-defined Inclusion/Exclusion Criteria could apply.
  • .

Lab values

• Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina, NYHA class III or IV heart failure or uncontrolled arrhythmia within 6 months of study entry, severe QTc prolongation, concomitant risks for QTc prolongation.

Other

• Symptomatic central nervous system metastases.

• Male or female ≥ 18 years.
• Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors.
  • Part A only:
  • \* Patients must be: a) progressed after standard therapies, b) intolerant of standard therapies, or c) with a tumor type without standard therapy.
  • Part B only:
• Cohort A: Patients with previously untreated, unresectable, locally advanced or metastatic GC/GEJ adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received one infusion of mFOLFOX6 plus nivolumab during the screening period.
• Cohort B: Patients with GC/GEJ adenocarcinoma who have radiologically progressed following one or two prior systemic therapies; adjuvant or neoadjuvant therapy could be regarded as one line of therapy only if disease progressed or recurred during these treatments or within 6 months or less after completion of these treatments.
• Cohort C: Patients with previously untreated, unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma; prior adjuvant or neoadjuvant therapy are allowed only if disease progressed or recurred at least 6 months after completion of these treatments. Patients may have received up to 2 infusions of Gemcitabine + albumin-bound paclitaxel (with one week between each infusion) during the screening period.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-1 .
• Patients with adequate cardiac, liver, renal function, etc.