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Antibody Drug Conjugate
SOT102 for Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01 Trial)
Phase 1 & 2
Waitlist Available
Led By Josep Tabernero, M.D., Ph.D.
Research Sponsored by SOTIO Biotech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of the patient's signing the icf until the end of the trial, assessed up to approximately 4 years
Awards & highlights
CLAUDIO-01 Trial Summary
This trial will look at the best dose and side effects of SOT102 given alone or with other cancer drugs for people with stomach or pancreatic cancer that has spread and cannot be removed by surgery.
Eligible Conditions
- Stomach Cancer
- Pancreatic Cancer
- Gastroesophageal Junction Cancer
CLAUDIO-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of the patient's signing the icf until the end of the trial, assessed up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of the patient's signing the icf until the end of the trial, assessed up to approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Parts A and B: The definition of the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT102 given as monotherapy and in combination with first-line SoC treatment
Parts C and D: The assessment of the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment
Secondary outcome measures
Part C (monotherapy): Clinical benefit rate (CBR) according to RECIST 1.1
Parts A and B (monotherapy and combination with SoC): Characterization of pharmacokinetics (PK) of total SOT102 and its derivates
Parts A and B (monotherapy and combination with SoC): Evidence of SOT102 activity in monotherapy in individual patients
+24 moreOther outcome measures
Parts C and D (monotherapy and combination with SoC): Relationship between the intensity of CLDN18.2 expression and clinical outcome
CLAUDIO-01 Trial Design
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.
Starting dose of SOT102 is 0.032 mg/kg. Dose levels are to be escalated according modified Fibonacci scheme.
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Who is running the clinical trial?
SOTIO BiotechLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
Sotio Biotech Inc.Lead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
Josep Tabernero, M.D., Ph.D.Principal InvestigatorVall d'Hebron University Hospital (HUVH)
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have had lung problems like interstitial pneumonitis or pulmonary fibrosis in the past.You have moderate to severe peripheral nerve problems.Your liver function tests should be within a certain range, and if you have liver involvement, there are different limits for AST and ALT levels.Your albumin level in the blood is 3.0 mg/dL or higher.Your disease is too advanced to be treated with surgery.You have received treatment with any medication targeting CLDN18.2 in the past.You have a medical reason that prevents you from taking the standard first-line treatment.Your prothrombin time or international normalized ratio (INR) should be within a certain range.Your white blood cell count, platelet count, and hemoglobin levels are within a certain range.Your kidneys work well enough to filter out waste products.You have been diagnosed with advanced or metastatic stomach or GEJ adenocarcinoma.You have advanced or spreading stomach or gastroesophageal junction cancer.You have an infection that needs treatment with medication within 7 days before the start of the trial.You have a history of HIV, hepatitis B, or hepatitis C.You have a type of cancer in the stomach, gastroesophageal junction (GEJ), or pancreas that has spread to other parts of the body.You have a deficiency in an enzyme called dihydropyrimidine dehydrogenase.You have been diagnosed with advanced or metastatic pancreatic cancer.You have a brain tumor that is causing symptoms. If you have brain tumors but no symptoms and have not been taking certain medications, you may still be eligible if the tumors have not changed for at least 60 days.You or someone in your family has a heart condition called congenital long QT syndrome.You have less than 1 gram of protein in your urine over a 24-hour period.Your ability to perform daily activities is not significantly limited.You have evidence that shows your pancreatic cancer has spread or is advanced.You have received at least two treatments for your advanced cancer. If you have HER2 overexpression, you must have received anti-HER2 therapy for stomach cancer.You have already received at least one type of treatment for advanced or spreading pancreatic cancer.Your tumors in the stomach do not have a specific protein called HER2.
Research Study Groups:
This trial has the following groups:- Group 1: SOT102
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for participants in this scientific experiment?
"According to clinicaltrials.gov, this experiment is currently recruiting participants as of November 25th 2022 - the day it was most recently modified. The trial was initially advertised on March 31st 2022."
Answered by AI
How many subjects are participating in the experiment?
"Affirmative. According to clinicaltrials.gov, this medical experiment is actively searching for volunteers; it was first posted on March 31st 2022 and most recently updated November 25th of the same year. The study aims to recruit 269 patients from 2 different sites."
Answered by AI
What is the overarching objective of this research endeavor?
"The primary purpose of this clinical trial, with a duration potentially stretching up to 4 years, is to find the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dosage (RP2D) for SOT102 when administered as both monotherapy and in combination with first-line standard-of-care treatment. Secondary outcomes include recording participant deaths, related adverse events and Serious Adverse Events across Parts A & B - mono therapy & combo SoC; C & D - Mono Therapy & Combo SoC respectively."
Answered by AI
Who else is applying?
What site did they apply to?
Cleveland Clinic Main Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I was diagnosed with Pancreatic Cancer(Neuro Endocrine Carcinoma) with Mets in both lobes of liver few months back(April-2023) during routine checkup,
Took 6 chemo cycles(Carboplatin + Etoposide) which completed in July2023 and taking Durvalumab Immunotherapy in parallel - Took 7 cycle of Immuno till today & still continuing. No physical or psychological problems.
Perfectly fine to travel anywhere for treatment & trial and I hold a valid US visa also if travelling to hospital is required.
Detailed Summary -
> Patient Summary -
> My name is Ankit Dubey, Male 39, residing in India, willing to travel for treatment at your centre.
>
> Let me give you the background - Mar-Apr 2023, during routine checkup, I was diagnosed with Pancreatic cancer in Lucknow, INDIA with Metastasis spread across both lobes of liver ( I guess, it's considered as stage 4 cancer).
>
> Next day I travelled to Tata Memorial hospital, Mumbai INDIA where they repeated all tests, including CT scan & BIOPSY.
>
> Since bilrubin was increasing and BIOPSY report was not finalized so they gave 1st round of Chemo on 26th March (only Carboplatin-5AUC) to control the disease/bilirubin since bilrubin was increased to 6 from 4 in 4days and came back to 4 in 2 days just after 1st small dose of chemo.
>
> In hystopathology/ biopsy report - they identified it as Neuroendocrine carcinoma (high grade) and then gave another round of full chemo(Carboplatin + Etoposide) on 11,12 &13th April (after around 2weeks interval from 1st small chemo and prescribed 4 more cycles of full chemo(Carboplatin + Etoposide) cycle at interval of every 21 days then after.
>
> Did PetSCAN just before the 2nd cycle of full Chemo and found that Pancreatic Tumor was reduced from 6cm dia to around 1.5cm and METS in liver also shrunken significantly. (Initial CT & Pet SCAN report attached.
PatientReceived 1 prior treatment
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