Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called SOT102 to treat patients with advanced or metastatic pancreatic cancer. It aims to find the best dose and see how well the drug works alone or with other standard treatments.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications. However, if you are on corticosteroids or anticonvulsants for central nervous system metastases, you may not be eligible. It's best to discuss your specific medications with the trial team.
What data supports the idea that SOT102 for Gastric and Pancreatic Adenocarcinoma is an effective treatment?
The available research does not provide specific data on the effectiveness of SOT102 for treating gastric and pancreatic adenocarcinoma. Instead, it focuses on other aspects of gastric cancer, such as potential biomarkers and genetic factors. Without direct evidence or comparisons to other treatments, we cannot conclude that SOT102 is effective based on the provided information.12345
What safety data is available for SOT102 treatment?
Research Team
JT
Josep Tabernero, MD, PhD
Principal Investigator
Vall d'Hebron University Hospital (HUVH)
Eligibility Criteria
This trial is for adults with advanced or metastatic gastric or pancreatic adenocarcinoma. They must have tried at least two prior therapies (one for pancreatic cancer), not be pregnant, and agree to contraception. Excluded are those with severe preexisting conditions, recent major surgery, certain lung diseases, active infections, HIV/hepatitis B/C, or specific genetic deficiencies.Inclusion Criteria
Your disease can be measured or not according to a certain set of guidelines.
You must have already tried at least two different treatments for your advanced or metastatic disease. If you have HER2 overexpression, you must have already tried anti-HER2 therapy for stomach cancer.
You have a disease that has spread and cannot be treated with surgery.
See 19 more
Exclusion Criteria
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)
Major surgical intervention ≤28 days prior to ICF signature or incomplete wound healing after surgical intervention
You have had lung problems like interstitial pneumonitis or pulmonary fibrosis in the past.
See 9 more
Treatment Details
Interventions
- SOT102 (Antibody Drug Conjugate)
Trial OverviewThe trial tests SOT102 alone (Part A) and combined with standard chemotherapy (nab-paclitaxel/gemcitabine; Part B). It aims to find the maximum tolerated dose and recommended phase 2 dose of SOT102 as well as its effectiveness both alone (Part C) and in combination therapy (Part D).
Participant Groups
1Treatment groups
Experimental Treatment
Group I: SOT102Experimental Treatment1 Intervention
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SOTIO Biotech a.s.
Lead Sponsor
Trials
3
Recruited
270+
SOTIO Biotech
Lead Sponsor
Trials
2
Recruited
150+
Sotio Biotech Inc.
Lead Sponsor
Trials
2
Recruited
150+
Findings from Research
COMMD10 expression is significantly elevated in gastric adenocarcinoma (STAD) tissues compared to normal tissues, and higher levels of COMMD10 are associated with poorer overall survival and worse clinical outcomes for STAD patients.
The study suggests that COMMD10 may influence STAD prognosis through mechanisms related to m6A RNA modifications and immune cell infiltration, particularly involving macrophages.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Comprehensive analysis of COMMD10 as a novel prognostic biomarker for gastric cancer.Zhao, W., Lin, J., Cheng, S., et al.[2023]
Among 397 patients treated for gastric adenocarcinoma from 1999 to 2009, long-term survival rates improved significantly, with 5-year survival increasing from 38.7% in the first half of the decade to 49.2% in the latter half.
In-hospital mortality for patients who underwent curative resection decreased from 8.5% to 2.0%, and there was a notable shift towards using primary stents instead of exploratory surgeries or bypass procedures for non-curative cases.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Outcomes among patients treated for gastric adenocarcinoma during the last decade.Bringeland, EA., Wasmuth, HH., Johnsen, G., et al.[2022]
The study identified 114 differentially expressed genes (DEGs) in stomach adenocarcinoma (STAD) tissues compared to normal tissues, with 35 genes upregulated and 79 downregulated, highlighting potential targets for therapy.
Ten core genes (including COL1A1, FN1, and THBS2) were found to be significantly overexpressed in STAD tissues, suggesting they could serve as important prognostic biomarkers and therapeutic targets for future STAD treatments.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Identification of Potential Core Genes Associated With the Progression of Stomach Adenocarcinoma Using Bioinformatic Analysis.Yang, B., Zhang, M., Luo, T.[2022]
References
Comprehensive analysis of COMMD10 as a novel prognostic biomarker for gastric cancer. [2023]
Outcomes among patients treated for gastric adenocarcinoma during the last decade. [2022]
FGFR2, HER2 and cMet in gastric adenocarcinoma: detection, prognostic significance and assessment of downstream pathway activation. [2021]
Identification of Potential Core Genes Associated With the Progression of Stomach Adenocarcinoma Using Bioinformatic Analysis. [2022]
Prognostic value of nicotinamide adenine dinucleotide (NAD+) metabolic genes in patients with stomach adenocarcinoma based on bioinformatics analysis. [2023]
The novel somatostatin receptor 2/dopamine type 2 receptor chimeric compound BIM-23A758 decreases the viability of human GOT1 midgut carcinoid cells. [2021]
A phase Ib/IIa trial to evaluate the CCK2 receptor antagonist Z-360 in combination with gemcitabine in patients with advanced pancreatic cancer. [2022]
The hypofunctional effect of P335L single nucleotide polymorphism on SSTR5 function. [2022]
Gene transfer of somatostatin receptor type 2 by intratumoral injection inhibits established pancreatic carcinoma xenografts. [2019]
New somatostatin-drug conjugates for effective targeting pancreatic cancer. [2018]
HOXC10 overexpression promotes cell proliferation and migration in gastric cancer. [2020]
The effect of overexpression of the HOXD10 gene on the malignant proliferation, invasion, and tumor formation of pancreatic cancer cell PANC-1. [2022]
SMAD4 and TGFβR2 expression in pancreatic ductal carcinoma. [2020]
Evaluation of novel highly specific antibodies to cancer testis antigen Centrin-1 for radioimmunoimaging and radioimmunotherapy of pancreatic cancer. [2021]
Expression of Fibroblast Growth Factor 10 Is Correlated with Poor Prognosis in Gastric Adenocarcinoma. [2017]