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Antibody Drug Conjugate
SOT102 for Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01 Trial)
Phase 1 & 2
Recruiting
Led By Josep Tabernero, M.D., Ph.D.
Research Sponsored by SOTIO Biotech a.s.
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
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.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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).See study design
What are the potential side effects?
Potential side effects of SOT102 may include typical reactions associated with antibody drug conjugates such as fatigue, nausea, allergic reactions at the infusion site. The exact side effects will be further identified during the 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
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. 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer, such as FOLFIRINOX and gemcitabine plus nab-paclitaxel, work by disrupting cancer cell division and DNA repair mechanisms, leading to cell death. The new therapeutic agent SOT102, being studied in clinical trials, is an antibody-drug conjugate that targets specific markers on cancer cells to deliver cytotoxic agents directly to the tumor.
This targeted approach aims to enhance the effectiveness of standard chemotherapy while potentially reducing side effects, offering a promising advancement for pancreatic cancer patients.
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Who is running the clinical trial?
SOTIO Biotech a.s.Lead Sponsor
2 Previous Clinical Trials
310 Total Patients Enrolled
SOTIO BiotechLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
Sotio Biotech Inc.Lead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
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.
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