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CompletedNCT04672434Updated Dec 9, 2024

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

A Phase 1 interventional study of Sym021 and Sym024 in Metastatic Cancer and Solid Tumor, sponsored by Symphogen A/S. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by Symphogen A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2024, 1 year 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

Part 1 of this study will 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 2 of this study will 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 2a of this study will assess the safety and tolerability of Sym024 when first administered as a single agent during Cycle 1 (safety lead-in) followed by administration in combination with Sym021 during Cycle 2 and subsequent cycles.

Part 3 of this study will assess the safety of Sym024 when administered alone or in combination with Sym021 in expanded cohorts of patients with solid tumor malignancies.

April 2024: The above was the study design at trial start. Per protocol, implementation of a part 3 would require an amendment. However, this was never done as it was decided not to include a part 3.

02

Conditions studied

  • Metastatic Cancer
  • Solid Tumor

Keywords

  • Locally advanced/unresectable
  • Metastatic solid tumor
  • Anti-PD-1
  • PD-1
  • PD1
  • CD73
  • Squamous cell carcinoma of the head and neck (SCCHN)
  • Non-small-cell lung carcinoma-adenocarcinoma histology subtype (NSCLC-Adeno)
  • Pancreatic ductal adenocarcinoma (PDAC)
  • Cholangiocarcinoma (CCA)
  • Colorectal carcinoma (CRC)
  • Gastric carcinoma (GC)
  • Esophageal carcinoma (EsoCA)
  • Mesothelioma (Meso)
  • Sym021
  • Sym024
  • Head and neck squamous cell carcinoma (HNSCC)
  • Cervical carcinoma (CC)
03

In context

Neoplasms

9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 7,258 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Symphogen A/S is the lead sponsor of 14 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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):

    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.

Exclusion criteria

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Sym024 Dose Level 1

    Part I, Sym024 monotherapy dose level 1

    Drug: Sym024

  • Experimental
    Sym024 Dose Level 2

    Part I, Sym024 monotherapy dose level 2

    Drug: Sym024

  • Experimental
    Sym024 Dose Level 3

    Part I, Sym024 monotherapy dose level 3

    Drug: Sym024

  • Experimental
    Sym024 Dose Level 4

    Part I, Sym024 monotherapy dose level 4

    Drug: Sym024

  • Experimental
    Sym024 Dose Level -1

    Part I, Sym024 monotherapy dose level -1. Evaluate only if needed based on tolerability

    Drug: Sym024

  • Experimental
    Sym021+Sym024 Dose Level 2

    Part II, Sym021 in combination with dose level 2 of Sym024

    Drug: Sym021 · Drug: Sym024

  • Experimental
    Sym021+Sym024 Dose Level 3

    Part II, Sym021 in combination with dose level 3 of Sym024

    Drug: Sym021 · Drug: Sym024

  • Experimental
    Sym021+Sym024 Dose Level 4

    Part II, Sym021 in combination with dose level 4 of Sym024

    Drug: Sym021 · Drug: Sym024

  • Experimental
    Sym021+Sym024 Dose Level 5

    Part IIa, Sym024 monotherapy and in combination with Sym021

    Drug: Sym021 · Drug: Sym024

  • Experimental
    Sym021+Sym024 Dose Level 1

    Part II, Sym021 in combination with dose level 1 of Sym024. Evaluate only if needed based on tolerability

    Drug: Sym021 · Drug: Sym024

  • Experimental
    Dose Expansion Sym021 (+Sym024)

    Part III, dose expansion Sym024 and/or Sym021+Sym024

    Drug: Sym021 · Drug: Sym024

Interventions

  • DrugSym021

    Sym021 is a humanized anti-PD-1 antibody.

    Also known as: Anti-PD-1

  • DrugSym024

    Sym024 is an anti-CD73 antibody.

06

What researchers measure

Primary outcomes

  1. Part I: To evaluate the incidence, severity and relationship of (S)AEs to establish the MTD/MAD of Sym024 monotherapy.

    Assess the safety and tolerability of Sym024 monotherapy on a Q2W schedule (every two weeks). Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1

    Time frame: 28 days

  2. Part II: To evaluate the incidence, severity and relationship of (S)AEs to establish MTD/MAD of Sym024 in combination with Sym021.

    Assess the safety and tolerability of the sequential escalating doses of Sym024 in combination with Sym021 on a Q2W schedule. Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1

    Time frame: 28 days

  3. Part III: To evaluate the incidence, severity and relationship of (S)AEs to further assess safety of Sym024 when administered alone or in combination with Sym021.

    Assess the safety and tolerability of Sym024 and/or Sym021+Sym024 on a Q2W schedule. Assessment based on the occurrence of AEs

    Time frame: 12 months

Secondary outcomes

  1. Evaluation of the immunogenicity of Sym024 as a single agent and in combination with Sym024

    Serum sampling to assess the potential for anti-drug antibody (ADA) formation

    Time frame: 24 months

  2. Evaluation of objective response (OR) or stable disease (SD)

    Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST)

    Time frame: 24 months

  3. Time to progression (TTP) of disease

    Based on time of enrollment to first evidence of progression on imaging studies, as assessed by RECIST v1.1 and iRECIST

    Time frame: 24 months

  4. Area under the concentration-time curve in a dosing interval (AUC)

    Will be estimated using non-compartmental methods and actual timepoints

    Time frame: 24 months

  5. Maximum concentration (Cmax)

    Will be derived from observed data

    Time frame: 24 months

  6. Time to reach maximum concentration (Tmax)

    Will be derived from observed data

    Time frame: 24 months

  7. Trough concentration (Ctrough)

    Will be derived from observed data

    Time frame: 24 months

  8. Terminal elimination half-life (T½)

    Will be estimated using non-compartmental methods and actual timepoints

    Time frame: 24 months

  9. Clearance (CL)

    Will be estimated using non-compartmental methods and actual timepoints

    Time frame: 24 months

07

Study locations

4 sites
  • START Midwest
    Grand Rapids, Michigan 49545, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • NEXT Oncology
    San Antonio, Texas 78229, United States
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 1Z5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04672434
Lead sponsor
Symphogen A/S
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Nov 19, 2020
Primary completion
Nov 22, 2024
Completion
Nov 22, 2024
Last update
Dec 9, 2024

Study contacts

N. Lakhani, MD PhD
principal investigator · START Midwest, USA

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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