A Phase I, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of Sym024 (Anti-CD73) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies

Study Identifier:
Sym024-01
CT.gov Identifier:
NCT04672434
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To see if Sym024 is safe and tolerable as monotherapy and in combination with Sym021 in patients with solid tumor malignancies.

Part I: To assess the safety and tolerability to establish the maximum tolerated dose (MTD) (or the maximum administered dose [MAD]) and/or the selected dose(s) of Sym024 in patients with solid tumor malignancies.

Part II: To assess the safety and tolerability to establish the MTD (or the MAD) and/or the selected dose(s) of Sym024 when administered in combination with Sym021 in patients with solid tumor malignancies.

Part III: To assess the safety of Sym024 when administered alone or in combination with Sym021 in expanded cohorts of patients with solid tumor malignancies.

Following assessment of single agent S095024 (100 to 1500 mg IV Q2W) in part I, the safety and tolerability of S095024 (300 to 1500 mg IV Q2W) was assessed in combination with Sym021 (200 mg IV Q2W) in part II.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Metastatic Cancer
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Sym024 Dose Level 1
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  • Drug: Experimental: Sym024 Dose Level 2
  • Drug: Experimental: Sym024 Dose Level 3
  • Drug: Experimental: Sym024 Dose Level 4
  • Drug: Experimental: Sym024 Dose Level -1
  • Drug: Experimental: Sym021+Sym024 Dose Level 2
  • Drug: Drug: Sym024
  • Drug: Experimental: Sym021+Sym024 Dose Level 3
  • Drug: Experimental: Sym021+Sym024 Dose Level 4
  • Drug: Experimental: Sym021+Sym024 Dose Level 5
  • Drug: Experimental: Sym021+Sym024 Dose Level 1
  • Drug: Experimental: Dose Expansion Sym021 (+Sym024)
  • Drug: single agent S095024 (100 to 1500 mg IV Q2W) in part I,
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion 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):
    • Squamous cell carcinoma of the head and neck
    • Non-small-cell lung carcinoma-adenocarcinoma histology subtype
    • Pancreatic ductal adenocarcinoma
    • Cholangiocarcinoma
    • Colorectal carcinoma (microsatellite stable [MSS] and microsatellite instability-high [MSI-H] phenotypes)
    • Gastric carcinoma (includes gastroesophageal carcinoma)
    • Esophageal carcinoma (includes squamous cell and adenocarcinoma)
    • Mesothelioma (pleural and peritoneal)
    • 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
    Exclusion 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).

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Metastatic Cancer
    Solid Tumor