Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Biliary Tract Carcinomas

• Status: Active, not recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinoma 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symphogen A/S
• Treatments: Irinotecan

Criteria

Inclusion Criteria:

• Patients with locally advanced or metastatic biliary tract carcinoma including adenocarcinoma of the intra- and/or extra-hepatic bile ducts and gallbladder carcinoma.

Patients with ampullary cancers are excluded.

• Patients must only have received and progressed on first-line gemcitabine and platinum-based chemotherapy in metastatic/advanced setting and should not have received prior anti-PD-(L)1 therapy. Patients with known fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement, or isocitrate dehydrogenase 1 (IDH1) mutation will be excluded.

• Patients with measurable disease according to RECIST v1.1

• Patients with an ECOG PS of 0 or 1, and anticipated life expectancy of ≥3 months

• Patients must have adequate organ function as indicated by laboratory values

• Adequate contraception required as appropriate

Exclusion Criteria:

• Patients with central nervous system (CNS) malignancy, untreated or unstable metastases

• Patients with significant cardiovascular disease

• Patients with

1. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to the first study drug dose

2. Active uncontrolled bleeding or a known bleeding diathesis

• 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 or with 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 IO therapies.

• Patients must not be on warfarin, strong cytochrome P450 (CYP) 3A4 inducers, strong CYP3A4 inhibitors, or strong UGT1A1 inhibitors.

• Patients with a history of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapy

• 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