Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01)

SOTIO

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: SOT102

Study type: Interventional

Funder types: Industry

Identifiers

NCT05525286

2021-005873-25 (EudraCT Number)

2023-504441-31-00 (EU Trial (CTIS) Number)

SN201

Details and patient eligibility

About

This trial will assess the MTD and RP2D of SOT102 administered as monotherapy (Part A) and in combination with first-line SoC treatment (nab-paclitaxel/ gemcitabine; Part B) and efficacy of SOT102 administered as monotherapy (Part C) and in combination with first-line SoC treatment (Part D) in patients with advanced or metastatic pancreatic adenocarcinoma.

Full description

The trial will have the following parts:

• Part A: Dose escalation, first-in-human, single-agent phase 1 trial of SOT102 in advanced/metastatic pancreatic cancer patients with unmet medical need (CLDN18.2 agnostic)
• Part B : Phase 1b dose escalation combination trial of SOT102 in combination with nab-paclitaxel/gemcitabine as SoC regimen for first-line treatment of patients with advanced/metastatic pancreatic cancer (CLDN18.2 agnostic)

Once an RP2D in the respective phase 1 evaluation (Part A and Part B) has been identified, expansion parts (Part C and Part D) are planned:

• Part C : Single-agent SOT102 expansion at RP2D identified in Part A in pancreatic cancer after one or more prior systemic therapies (second+ line) for locally advanced or metastatic disease (CLDN18.2 positive)
• Part D : SOT102 in combination with nab- paclitaxel/gemcitabine for first-line treatment expansion at RP2D identified in Part B in pancreatic cancer (CLDN18.2 positive)

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

160 participants in 1 patient group

SOT102

Experimental group

Description:

SOT102 is administered as intravenous infusion over 45 minutes as monotherapy or in combination with established standard of care therapy, every 14 days until the disease progression or intolerance to SOT102. SoC therapy is administered as per approved local standards. Patients will receive premedication with corticosteroids (4 mg dexamethasone twice daily) the day before, the day of (at least one hour prior), and the day after each SOT102 administration. Starting dose of SOT102 is 0.032 mg/kg. Dose levels are to be escalated according modified Fibonacci scheme.

Treatment:

Drug: SOT102