A study to evaluate the safety and efficacy of SOT102 as a single drug or in combination with standard of care treatment, in patients with stomach and pancreas cancer
- Conditions
- Gastric and pancreatic adenocarcinomaMedDRA version: 21.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-005873-25-BE
- Lead Sponsor
- SOTIO Biotech a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 269
Inclusion criteria applicable to all trial parts
Age =18 years
Written informed consent given prior to any trial-specific procedures
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
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, and one of the following conditions applies:
Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile.
A WOCBP who agrees to use a highly effective contraceptive method during the treatment period and for at least 9 months after the last dose of SOT-102 or first-line SoC treatment (whichever occurs later)
Male patients must agree to use a condom during treatment and for 9 months after SOT102 or first-line SoC treatment discontinuation. Male pat wishing to become a father during or after the trial should consider sperm preservation. WOCBP partner of male part should use highly effective contrac methods for 9 months after SOT102 or first-line SoC treat disc
Left ventricular ejection fraction (LVEF) =50% as determined by echocardiography or nuclear medicine methodology (multiple gated acquisition scanning [MUGA])
QTcF interval <450 msec on screening electrocardiogram (ECG)
Patient is, in the judgement of the investigator, an appropriate candidate for experimental therapy
Patient agrees not to participate in other interventional clinical trials while enrolled in the present trial (with the exception of survival follow-up period)
All previous cancer therapies for locally advanced gastric/pancreatic cancer and any agents that have not received regulatory approval for any indication must have been discontinued prior to day 1 of cycle 1.
Part A
Adequate tumor tissue or cytology sample or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
Patient has advanced inoperable or metastatic disease
Patient has received and/or has been determined to be intolerant of all standard of care therapy known to confer clinical benefit
Measurable or non-measurable disease according to RECIST 1.1
Histological or cytological evidence of adenocarcinoma of the stomach or GEJ or pancreas that is advanced or metastatic
PartB
Adequate tumor tissue or cytology sample (FFPE blocks) or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy
Patient has advanced inoperable or metastatic disease
Patient must have at least one measurable lesion according to RECIST 1.1
Patients with gastric/GEJ adenocarcinoma (gastric B)
Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic
Must have HER2-negative tumors
Patients with pancreatic adenocarcinoma (pancreatic B)
Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic
PartC
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.
Patient has advanced inoperable or metastati
Prior therapy with any agent directed at CLDN18.2
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
Patient has been previously treated with the maximum cumulative dose of anthracyclines
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
Patients with hepatitis B will be eligible if:
•there is serologic evidence of a resolved prior HBV infection (HBsAg-negative and anti-HBc–positive
Patients with hepatitis C will be eligible if:
•they have completed curative antiviral treatment and have HCV viral load below the limit of quantification
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 =3 heart failure, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, myocardial infarction, cerebrovascular accident or hypertensive crisis within 6 months prior to day 1 of cycle 1
History of major ventricular arrhythmias
History or family history of congenital long QT syndrome
Bradycardia (<50 beats per minute)
Family history of sudden cardiac death before age 50
Major surgical intervention =28 days prior to ICF signature or incomplete wound healing after surgical intervention
Hypersensitivity or intolerance to any component of trial intervention
Vaccination with a live or live-attenuated vaccine within 30 days prior the first dose of trial interventions
Part A Part C
Any prior systemic therapy for metastatic cancer other than gastric or pancreatic cancer.
Part B
General. Patients must not have received any systemic therapy for metastatic desease. 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
Patients with gastric/GEJ adenocarcinoma (gastric B):
Dihydropyrimidine dehydrogenase (DPD) deficiency
Patient has been treated with immunosuppressive medications =14 days prior to day 1 of cycle 1.
Concomitant use of drugs known to prolong the QT/QTc interval
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
Part D
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.
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