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CompletedPhase 1NCT04672434
Official study title

Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies

Study summary

The primary purpose of this study is to see if Sym024 is safe and tolerable as monotherapy and in combination with Sym021 in patients with solid tumor malignancies.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSym021 and Sym024

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 9, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Symphogen A/S

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Symphogen A/S
Interventions being studied
Drug: Sym021; Drug: Sym024
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Male or female patients, ≥18 years.
  • Documented (histologically or cytologically proven), locally advanced or metastatic solid tumor malignancy (must be one of the following): 1. Squamous cell carcinoma of the head and neck 2. Non-small-cell lung carcinoma-adenocarcinoma histology subtype 3. Pancreatic ductal adenocarcinoma 4. Cholangiocarcinoma 5. Colorectal carcinoma (microsatellite stable \[MSS\] and microsatellite instability-high \[MSI-H\] phenotypes) 6. Gastric carcinoma (includes gastroesophageal carcinoma) 7. Esophageal carcinoma (includes squamous cell and adenocarcinoma) 8. Mesothelioma (pleural and peritoneal) 9. Cervical carcinoma (CC) (includes adeno, squamous and mixed adeno-squamous carcinoma histology subtypes)
  • Malignancy that is not currently amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
  • Measurable disease according to RECIST v1.1.
  • Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit.
  • Agreeing to mandatory tumor tissue biopsies (2 total).
  • ECOG PS of 0 or 1.
  • Adequate organ function as indicated by the following laboratory values.
  • Adequate contraception required as appropriate.
Reasons someone may not be able to joinExclusion criteria
  • Central nervous system (CNS) malignancies.
  • Clinically significant cardiovascular disease or condition.
  • Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study drug(s).
  • Active uncontrolled bleeding or a known bleeding diathesis.
  • Significant ocular disease or condition.
  • Significant pulmonary disease or condition.
  • Current or recent (within 6 months) significant gastrointestinal disease or condition.
  • Active, known or suspected autoimmune disease.
  • History of organ transplantation (i.e., stem cell or solid organ transplant).
  • Known history of human immunodeficiency virus (HIV) or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Any other serious/active/uncontrolled infection.
  • History of significant toxicities associated with previous administration of immune checkpoint inhibitors.
  • Known or suspected hypersensitivity to any of the excipients of formulated study drug.
  • Unresolved \>Grade 1 toxicity associated with any prior antineoplastic therapy.
  • Inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to the first dose of study drug(s).
  • Any other serious, life-threatening, or unstable preexisting medical condition (aside from the underlying malignancy). Therapeutic Exclusions
  • Prior therapy with Sym024 or other inhibitors of CD73, CD39 or adenosine receptors ADORA2A, ADORA2B.
  • Part II and Part III, prior anti-PD-(L)1 therapy, except for indications where it is approved.
  • Any antineoplastic agent for the primary malignancy (standard or investigational) within 4 weeks or 5 elimination half-lives.
  • Any other investigational treatments within 2 weeks prior to the first dose of study drug(s).
  • Radiotherapy, with exceptions.
  • Live vaccines against infectious diseases 4 weeks prior to the first dose of study drug(s).
  • Immunosuppressive or systemic glucocorticoids therapy (\>10 mg daily prednisone or equivalent) within 2 weeks prior to the first dose of study drug(s), with exceptions.
  • Prophylactic use of hematopoietic growth factors within 1 week prior to the first dose of study drug(s).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • START MidwestGrand Rapids, Michigan
  • MD Anderson Cancer CenterHouston, Texas
  • NEXT OncologySan Antonio, Texas
  • Princess Margaret Cancer CentreToronto, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 9, 2024. Always confirm current availability with the study team.

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