Status and phase
Conditions
Treatments
About
The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations
Full description
The study will evaluate safety and efficacy in patients with:
The trial is set up as 3 sub-studies.
August 2021 : Based upon results from a recent per protocol Interim Analysis (IA) it is has been decided as of 3rd of August 2021 to stop further enrollment into Sub-study 1 Arm A (Sym021+Sym022). Future patients will be allocated to either Sub-study 1 Arm B (Sym021+Sym023) or Sub-study 2 (Sym021+Sym023+irinotecan).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
For Sub-study 1 and 2:
For Sub-study 3:
For all Sub-studies :
Exclusion criteria
Patients with central nervous system (CNS) malignancy, untreated or unstable metastases
Patients with significant cardiovascular disease
Patients with
Patients with a significant pulmonary disease or condition
Patients with a current or recent (within 6 months) significant gastrointestinal disease or condition
Patients with Gilbert's syndrome or patients with UGT1A1*28 homozygosity (also known as UGT1A1 7/7 genotype)
Patients with a significant ocular disease or condition
Patients with an active, known or suspected autoimmune disease
Patients with any other serious/active/uncontrolled infection
Patients with a history of organ transplantation
Patients with human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or active infection with hepatitis B virus or hepatitis C virus
Prior therapy with irinotecan
For Sub-study 1 and Sub-study 2: Anti-PD-(L)1, anti -LAG-3* or anti-TIM-3 containing regimen, or combination with any other systemic or localized therapy or any other immuno-oncology (IO) therapies.
For Sub-study 3: Anti-TIM-3 containing regimen, or combination with any other systemic or localized therapy or any other IO therapies (other than anti-PD-(L)1 agents).
Patients must not be on warfarin, if they have a history of acute immune-related thrombocytopenia; patients must not be on strong cytochrome P450 (CYP) 3A4 inducers, strong CYP3A4 inhibitors, or strong UGT1A1 inhibitors.
Patients with a known or suspected hypersensitivity to any of the excipients of formulated study drug
Patients with unresolved >Grade 1 toxicity associated with any prior antineoplastic therapy
Sub-study 1 and Sub-study 2: Patients with known FGFR2 fusion or rearrangement, or IDH1 mutation.
For Sub-study 3: Patients with a history of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapy.
Primary purpose
Allocation
Interventional model
Masking
78 participants in 4 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal