Advanced and metastatic gastrointestinal cancer MedDRA version: 21.0 Level: PT Classification code 10061534 Term: Oesophageal squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10030137 Term: Oesophageal adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10017
Conditions
Interventions
Product Name: Tocilizumab
Product Code: [NA]
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Current Sponsor code: NA
Conc
Sponsors
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant must be >=18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent. Participants with: - Sub-study01: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic esophageal cancer of the squamous cell carcinoma subtype - Sub-study02: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ. - Sub-study03: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic HCC, or clinically by AASLD criteria in cirrhotic patients. - Sub-study04: Histologically or cytologically confirmed diagnosis of advanced unresectable or mCRC. Only patients with non-MSI-H disease are eligible. Participants (all sub-studies) must have at least one measurable lesion Mandatory baseline biopsy for the first 20 participants to enroll in sub-study01, sub-study02 and sub-study04. On-treatment biopsy for at least 20 participants in sub-study04. On-treatment biopsies are otherwise optional per Investigator’s discretion for the other cohorts. Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees: - to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment - and to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment. Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment. Capable of giving signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 210
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Eastern Cooperative Oncology Group (ECOG) performance status of >=2 - Poor organ function - Active brain metastases or leptomeningeal disease. - History of allogenic or solid organ transplant. - Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery within 28 days prior to first IMP administration - Comorbidity requiring corticosteroid therapy - Antibiotic use (excluding topical antibiotics) <=14 days prior to first dose of IMP - Severe or unstable cardiac condition within 6 months prior to starting study treatment - Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years - Participants with baseline SpO2 <=92% (without oxygen therapy). - Participant has received prior IL2-based anticancer treatment. - Participants on sub-study02 cohort B1 and B2 or sub-study 04 – cohort D1 with prior treatment with an agent that blocks the PD-1/PD-L1 pathway. - Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the antitumor activity of SAR444245 in combination with other anticancer therapies;Secondary Objective: - To assess the safety of SAR444245 when combined with other anticancer therapies - To assess other indicators of antitumor activity - To assess the pharmacokinetics of SAR444245 when given in combination with other anticancer therapies - To assess the immunogenicity of SAR444245 - Only for sub study 04 – Cohort D2: To assess active concentrations of cetuximab when given in combination with SAR444245 ;Primary end point(s): Objective Response Rate (ORR);Timepoint(s) of evaluation of this end point: Baseline to the date of first documentation of progression, assessed approximatively up to 9 months after the first dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Assessment of SAR444245 safety profile when combined with other anti-cancer therapies 2- Time to response 3- Duration of response 4- Clinical benefit rate 5- Progression-free survival 6- Concentrations of SAR444245 7- Incidence of anti-drug antibodies (ADAs) against SAR444245 8- Ctrough of infusion of cetuximab 9- Cend of infusion of cetuximab;Timepoint(s) of evaluation of this end point: 1:SAE:from 1st IMP dose up to 90 days after the last dose of IMP AE/TEAE:from 1st IMP dose up to 30 days after the last dose of IMP 2to5:Baseline to the date of first documentation of progression, assessed approximatively up to 18 months after the last patient-in 6:At Day1, 2, 3 of Cycle1 and Day 1 of Cycle 2-4-7-10 + every 5th cycle (each cycle is 21days), maximum is up to approximately 24 months 7:At Day 1 and 15 of Cycle1, at Day 1 of Cycle 2-4-7-10 + every 5th cycle and 30 days after last IMP administration, maximum is up to approximately 24 months 8:Day1 of Cycle1-2-4-7-10 + every 5th cycle and 30 days after last IMP administration, maximum is up to approximately 24 months 9:Day1 of Cycle1-2-4-7-10 + every 5th cycle, maximum is up to approximately 24 months | — |
Countries
Belgium, China, France, Germany, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, United States
Contacts
Public ContactContact Point
SANOFI S.r.l.
Outcome results
None listed