A Multicentric Phase I/II Trial to Evaluate the Safety and Efficacy of SOT102 as Monotherapy and in Combination With Standard of Care Treatment in Patients With Gastric and Pancreatic Adenocarcinoma
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Study Summary
To evaluate SOT102 in patients with gastric and pancreatic cancer.
To assess the MTD and RP2D of SOT102 administered as monotherapy and in combination with first-line SoC treatment in patients with advanced inoperable or metastatic gastric/GEJ adenocarcinoma or inoperable or metastatic pancreatic adenocarcinoma.
To evaluate SOT102, a Claudin 18.2 antibody-drug conjugate, for treatment of gastric and pancreatic cancers.
The combination arms will be the first clinical evaluation of SOT102’s potential as a first-line cancer treatment in combination with current standard of care. In the gastric cancer arm, SOT102 will be combined with mFOLFOX plus nivolumab. In the pancreatic cancer arm, SOT102 will be combined with Nab-paclitaxel plus gemcitabine.
To assess the safety and preliminary efficacy of SOT102. SOTIO is progressing dose-finding studies in the trial’s monotherapy arm, in which SOT102 is used as a later-stage treatment. In the trial’s combination arm, by contrast, SOT102 will be dosed in combination with standard-of-care as a first-line treatment for patients with advanced/metastatic gastric/gastroesophageal junction (GEJ) or pancreatic cancers.
- All Parts (key criteria)
- Hematologic: Absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥9 g/dL
- Hepatic: Bilirubin ≤1.5× upper limits of normal (ULN), ALT and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN
- Renal: Creatinine clearance ≥60 mL/min calculated by Cockcroft-Gault formula
- Prothrombin time/international normalized ratio (INR) ≤1.5×ULN
- Albumin ≥3.0 mg/dL
- Proteinuria <1 g/24 hours
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Estimated life expectancy ≥3 months as per investigator's assessment
- A female patient is eligible to participate if she is not pregnant, not breastfeeding, not of childbearing potential/ agreed with contraception
- Part A
- Patient has advanced inoperable or metastatic disease
- Patient has no better treatment option available
- Measurable or non-measurable disease according to RECIST 1.1
- Histological or cytological evidence of adenocarcinoma of pancreas that is advanced or metastatic
- Part B (in addition to relevant A criteria)*Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic (pancreas)
- Part C (in addition to relevant A criteria)*Must have received at least one prior systemic therapy for advanced or metastatic disease (pancreas)
- Part D (in addition to relevant B criteria)*Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced inoperable or metastatic (pancreas)
- Exclusion Criteria:
- All Parts (key criteria)
- Patient has received radiation therapy ≤14 days before day 1 of cycle 1 or has not recovered to grade ≤1 from treatment-related side effects
- Severe preexisting medical conditions as per judgement of the investigator (e.g., active gastric or GEJ ulcer with or without bleeding, complete or incomplete gastric outlet syndrome with persistent or repetitive bleeding)
- History of interstitial pneumonitis or pulmonary fibrosis
- Symptomatic central nervous system malignancy. Patients with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days.
- Patient has peripheral sensory neuropathy grade ≥2
- Active infection requiring systemic therapy within ≤7 days prior to day 1 of cycle 1
- History of major ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes)
- Bradycardia (<50 beats per minute)
- Family history of sudden cardiac death before age 50
- History or family history of congenital long QT syndrome
- Major surgical intervention ≤28 days prior to ICF signature or incomplete wound healing after surgical intervention
- Time since last transfusion of RBCs ≤14 days before cycle 1 day 1
- Vaccination with a live or live-attenuated vaccine within 30 days prior the first dose of trial interventions
- Part B/D (key)
- *Patients with contraindications to any component of the first-line SoC treatment
Clinical Study Information for Healthcare Providers
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