CompletedPhase 1

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

United States, Canada, France78 participantsStarted 2020-10-12

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This was a Phase 1 trial testing Sym021 combined with Sym022 or Sym023, sometimes alongside irinotecan — since Phase 1 trials are primarily focused on safety rather than proving a treatment works, what do the early safety results actually show, and what were the most common or serious side effects reported?
2The trial specifically focused on patients with biliary tract cancer or esophageal squamous cell carcinoma — given my specific diagnosis and how far my cancer has progressed, does my situation actually match the kind of patients who were enrolled in this study?
3Since this trial has now completed recruitment, does that mean the results are available yet, and would the findings from this study change any of the treatment options my care team is currently considering for me?
4The study tracked side effects serious enough to cause dose delays, interruptions, or patients stopping treatment entirely — how common was that, and how would those kinds of disruptions affect my day-to-day life or other treatments I might be receiving at the same time?
5Given that this was an early-phase combination immunotherapy trial and it has already completed, is there a follow-on trial, an expanded access program, or a standard treatment that might offer me a similar approach with more safety and effectiveness data behind it?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the preliminary efficacy of the combinations Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan in patients with BTC or ESCC by assessing overall response rates (ORRs) per Investigator assessment using RECISTv.1.1

Timeframe: Until disease progression or end of study, whichever comes first, assessed up to 24 months

To evaluate the incidence, severity, and relationship of (S)AEs collected from administration of the first dose of study drug until 30 days after the last dose of the 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irrinotecan)

Timeframe: Through study completion up to 30 days after last dose of the three combinations

To evaluate the AEs leading to dose interruption, dose delays, and permanent treatment stop of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym021+Sym023 +irinotecan)

Timeframe: Through study completion up to a maximum of 24 months

Trial details

NCT IDNCT04641871

SponsorSymphogen A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-03

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