Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01)
- Conditions
- gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) and pancreatic adenocarcinomaMedDRA version: 21.1Level: LLTClassification code: 10051971Term: Pancreatic adenocarcinoma Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10066354Term: Adenocarcinoma of the gastroesophageal junction Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504441-31-00
- Lead Sponsor
- SOTIO Biotech a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 298
Age =18 years, Part B- Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy, Part B- Patient has advanced inoperable or metastatic disease, Written informed consent given prior to any trial-specific procedures, Part B- Patient must have at least one measurable lesion according to RECIST 1.1, Part B - Patients with gastric/GEJ adenocarcinoma (gastric B) - Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic, Part B- Patients with gastric/GEJ adenocarcinoma (gastric B) - Must have HER2-negative tumors, Part B- Patients with pancreatic adenocarcinoma (pancreatic B) Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic, Part C- Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy. Tumor sample must have CLDN18.2 expression using a central immunohistochemistry method., Part C- Patient has advanced inoperable or metastatic disease, Part C- Measurable disease according to RECIST 1.1., Patient is, in the judgement of the investigator, an appropriate candidate for experimental therapy, Part C- Patients with gastric/GEJ adenocarcinoma (gastric C) - Must have received at least two prior systemic therapies for advanced or metastatic disease. If HER2 overexpression: must have received anti-HER2 therapy., Part C- Patients with pancreatic adenocarcinoma (pancreatic C) - Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic, Adequate organ function as assessed by the following parameters: hematologic; hepatic; renal; prothrombin time/international normalized ratio (INR); albumin; proteinuria; Serum concentrations of potassium, magnesium, and calcium within normal range, Part C- Patients with pancreatic adenocarcinoma (pancreatic C) - Must have received at least one prior systemic therapy for advanced or metastatic disease If HER2 overexpression: must have received anti-HER2 therapy., Part D- Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy. Tumor sample must have CLDN18.2 expression using a central immunohistochemistry method., Part D- Patient must have at least one measurable lesion according to RECIST 1.1. At least one measurable lesion must be outside of an earlier radiation field or must have progressed after radiation therapy, Part D- Patients with gastric/GEJ adenocarcinoma (gastric D) - Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced inoperable or metastatic, Part D- Patients with gastric/GEJ adenocarcinoma (gastric D) - Must have HER2-negative tumors, Part D- Patients with pancreatic adenocarcinoma (pancreatic D) - Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced inoperable or metastatic, Eastern Cooperative Oncology Group (ECOG) performance status =1, Patient agrees not to participate in other interventional clinical trials while enrolled in the present trial (with the exception of survival follow-up period), Estimated life expectancy =3 months as per investigator’s assessment, A female patient is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies: Not a
Patients with hepatitis B will be eligible if: •there is serologic evidence of a resolved prior HBV infection (HBsAg-negative and anti-HBc–positive, Major surgical intervention =28 days prior to ICF signature or incomplete wound healing after surgical intervention, 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, Hypersensitivity or intolerance to any component of trial intervention, Time since last transfusion of RBCs =14 days before cycle 1 day 1, Exclusion criteria specific to Part A Part C - Any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer., Exclusion criteria specific to Part B -General -Patients must not have received any systemic therapy for metastatic disease. Patients must not have received any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer. Patients with contraindications to any component of the first-line SoC treatment Patients with clinically active inflammatory bowel disease, Exclusion criteria specific to Part B - Patients with pancreatic adenocarcinoma (pancreatic B) Patients more clinically suitable (e.g., with BRCA1/2 mutation) to receive treatment with leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) as compared to nab-paclitaxel and gemcitabine according to the investigator’s opinion, Exclusion criteria specific to Part D- General - Patients must not have received any systemic therapy for metastatic disease. Patients must not have received any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer. Patients with contraindications to any component of the first-line SoC treatment Patients with clinically active inflammatory bowel disease, Exclusion criteria specific to Part D- Patients with pancreatic adenocarcinoma (pancreatic D) Patients more clinically suitable (e.g., with BRCA1/2 mutation) to receive treatment with FOLFIRINOX as compared to nab-paclitaxel and gemcitabine according to the investigator’s opinion, Patient has been previously treated with the maximum cumulative dose of anthracyclines, Patients with hepatitis C will be eligible if: •they have completed curative antiviral treatment and have HCV viral load below the limit of quantification, Severe preexisting medical conditions as per judgement of the investigator, 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 that is not clinically controlled before the signature of the ICF, Patients with HIV will be eligible if •CD4+ T-cell (CD4+) counts =350 cells/uL •they have no history of AIDS-defining opportunistic infections •they are not currently on HIV therapy, Alcohol or drug abuse as determined by the investigator, Psychiatric condition or social situation that, in the opinion of the investigator, preclude that the patient is able to comply with trial requirements, New York Heart Association class =2 heart failure, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, myocardial infarction, cerebrovascular accident
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method