SOT102 for Gastroesophageal Junction Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gastroesophageal Junction Cancer+2 MoreSOT102 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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
  • Gastroesophageal Junction Cancer
  • Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 27 Secondary · Reporting Duration: From the date of the patient's signing the ICF until the end of the trial, assessed up to approximately 4 years

Year 4
Parts A and B (monotherapy and combination with SoC): Number of participants with SOT102-related AEs
Parts A and B (monotherapy and combination with SoC): Number of participants with antibodies against SOT102
Parts A and B (monotherapy and combination with SoC): Number of participants with treatment-emergent AEs (TEAEs)
Dilatation and Curettage
Parts C and D (monotherapy and combination with SoC): Number of participants with TEAEs
Day 1
Parts A and B (monotherapy and combination with SoC): Characterization of pharmacokinetics (PK) of total SOT102 and its derivates
Year 4
Part C (monotherapy): Clinical benefit rate (CBR) according to RECIST 1.1
Parts A and B (monotherapy and combination with SoC): Evidence of SOT102 activity in monotherapy in individual patients
Parts C and D (monotherapy and combination with SoC): Duration of response (DoR) according to RECIST 1.1
Parts C and D (monotherapy and combination with SoC): Progression-free survival (PFS) according to RECIST 1.1
Parts C and D: The assessment of the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment
Year 4
Parts A and B (monotherapy and combination with SoC): Number of participants with AEs leading to premature discontinuation of SOT102
Parts C and D (monotherapy and combination with SoC): Characterization of PK of total SOT102 and its derivates
Parts C and D (monotherapy and combination with SoC): Number of participants with AEs leading to premature discontinuation of SOT102
Antibodies
Parts C and D (monotherapy and combination with SoC): Relationship between the intensity of CLDN18.2 expression and clinical outcome
Year 4
Parts C and D (monotherapy and combination with SoC): Overall survival (OS)
Year 4
Parts A and B (monotherapy and combination with SoC): Number of participants with clinical laboratory test abnormalities (coagulation, hematology, clinical chemistry and urinalysis) of grade 3 or higher graded according to NCI CTCAE version 5.0
Parts C and D (monotherapy and combination with SoC): Number of participants with clinical laboratory test abnormalities (coagulation, hematology, clinical chemistry and urinalysis) of grade 3 or higher graded according to NCI CTCAE version 5.0
Parts C and D (monotherapy and combination with SoC, patients with gastric cancer): Patient-reported quality of life questionnaire EORTC QLQ-C30 scores
Parts C and D (monotherapy and combination with SoC, patients with gastric cancer): Patient-reported quality of life questionnaire EORTC QLQ-STO22 scores
Parts C and D (monotherapy and combination with SoC, patients with pancreatic cancer): Patient-reported quality of life questionnaire EORTC QLQ-C30 scores
Parts C and D (monotherapy and combination with SoC, patients with pancreatic cancer): Patient-reported quality of life questionnaire EORTC QLQ-PAN26 scores
Year 4
Parts C and D (monotherapy and combination with SoC): Number of participants with SAEs
Year 4
Parts A and B (monotherapy and combination with SoC): Number of participants who died
Year 4
Parts C and D (monotherapy and combination with SoC): Number of participants who died
Parts C and D (monotherapy and combination with SoC): Patient-reported quality of life questionnaire EQ-5D-3L scores
Year 4
Parts A and B (monotherapy and combination with SoC): Number of participants with serious AEs (SAEs)
Day 28
Parts A and B (monotherapy and combination with SoC): Number of participants with DLTs
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

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

SOT102
1 of 1

Experimental Treatment

269 Total Participants · 1 Treatment Group

Primary Treatment: SOT102 · No Placebo Group · Phase 1 & 2

SOT102
Drug
Experimental Group · 1 Intervention: SOT102 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of the patient's signing the icf until the end of the trial, assessed up to approximately 4 years

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a key criterion.
You have a creatinine clearance of 60 mL/min or greater.
Prothrombin time/INR ≤ 1.5× ULN.
You have a performance status of 1 or 2.
You are female and not pregnant, not breastfeeding, not of childbearing potential/ agreed with contraception.