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Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01)
EU CTIS ID: 2023-504441-31-00
What this study is testing
Part A and Part B To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT102 given as monotherapy and in combination with first-line SoC treatment. MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT)-evaluable patients experiencing a DLT. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested. Part C and Part D To assess the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment by objective response rate
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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 woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming postmenopausal 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 contraception methods for 9 months after SOT102 or first-line SoC treat discontinuation.
- 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)
- 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 (Note: not applicable in France).
- Adequate tumor tissue from biopsy or fine needle aspiration (FNA) (formalin-fixed paraffin-embedded [FFPE] blocks), or unstained slides from archival biopsy available or willingness to undergo a fresh tumor biopsy.
- Part A- Patient has advanced inoperable or metastatic disease
- Part A- Patient has received and/or has been determined to be intolerant of all SoC therapy known to confer clinical benefit
- Part A- Measurable or non-measurable disease according to RECIST 1.1
- Part A- Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic
What rules you out
- 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 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.