Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies

Completed · Phase 1

Conditions studied: Metastatic Cancer, Solid Tumor

In brief

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

Key facts

Study ID

NCT04641871

Run by

Symphogen A/S

People needed

78

Starts

2020-10-12

Expected to finish

2024-06-03

Last updated by the study team

2024-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For Sub-study 1 and 2:
• 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 or be intolerant of 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. Prior anti-PD-(L)1 therapy may be allowed during the trial if regulatory approval for such therapy is obtained while this trial is enrolling.
• For Sub-study 3:
• Patients with with locally advanced or metastatic esophageal squamous cell carcinoma
• Patients must only have received and progressed on or be intolerant of first-line platinum-based chemotherapy in metastatic/advanced setting and should have received prior anti-PD-(L)1 therapy. Patients with mixed adenosquamous histology cancers are excluded.
• For all Sub-studies :
• 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

You may not qualify if…

• Patients with central nervous system (CNS) malignancy, untreated or unstable metastases
• Patients with significant cardiovascular disease
• Patients with
• Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to the first study drug dose
• 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
• 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.

Where it is running

• University of Colorado — Aurora, Colorado, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center (KUMC) — Westwood, Kansas, United States
• START Midwest — Grand Rapids, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mount Sinai - PRIME — New York, New York, United States
• Montefiore Medical Center PRIME — The Bronx, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• MD Anderson — Houston, Texas, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Centre Georges-François Leclerc, Department of Medical Oncology — Dijon, France
• Institut de Cancerologie de L'Ouest — Saint-Herblain, France
• Vall d'Hebron Institute of Oncology — Barcelona, Spain
• Hospital Universitario San Carlos — Madrid, Spain

Full record on ClinicalTrials.gov

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