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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 Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has advanced inoperable or metastatic disease
Histological or cytological evidence of adenocarcinoma of the stomach or GEJ or pancreas that is advanced or metastatic
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your disease is too advanced to be treated with surgery.
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You have a type of cancer in the stomach, gastroesophageal junction (GEJ), or pancreas that has spread to other parts of the body.
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You have been diagnosed with advanced or metastatic stomach or GEJ adenocarcinoma.
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Your ability to perform daily activities is not significantly limited.
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Your disease can be measured or not according to a certain set of guidelines.
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You have advanced or spreading stomach or gastroesophageal junction cancer.
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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.
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You have already received at least one type of treatment for advanced or spreading pancreatic cancer.

CLAUDIO-01 Trial 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of the patient's signing the icf until the end of the trial, assessed up to approximately 4 years for reporting.

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 more
Other 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.

Find a Location

Who is running the clinical trial?

Sotio Biotech Inc.Lead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
SOTIO BiotechLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
Josep Tabernero, M.D., Ph.D.Principal InvestigatorVall d'Hebron University Hospital (HUVH)

Media Library

SOT102 (Antibody Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05525286 — Phase 1 & 2
Stomach Cancer Research Study Groups: SOT102
Stomach Cancer Clinical Trial 2023: SOT102 Highlights & Side Effects. Trial Name: NCT05525286 — Phase 1 & 2
SOT102 (Antibody Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525286 — Phase 1 & 2

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
~90 spots leftby Apr 2025