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Metastatic CancerPhase 1NCT04672434

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

A Phase 1 study testing Sym021 and Sym024 in people with Metastatic Cancer and Solid Tumor, run by Symphogen A/S at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer, Solid Tumor
What is being tested?
Sym021 and Sym024
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
4 sitesin 2 countries
Study dates
19 Nov 2020to 22 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • START Midwest

    Grand Rapids, Michigan, 49545

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • NEXT Oncology

    San Antonio, Texas, 78229

Other trials in United States

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

About this study

Official title: A Phase 1, 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

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.

Being tested
Sym021, Sym024
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)
Medical subject headings
Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck, Cholangiocarcinoma, Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Mesothelioma, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sym021Drug

    Also called Anti-PD-1

    Sym021 is a humanized anti-PD-1 antibody.

  • Sym024Drug

    Sym024 is an anti-CD73 antibody.

Study groups in NCT04672434
Study groupRoleWhat they receive
Sym024 Dose Level 1ExperimentalPart I, Sym024 monotherapy dose level 1
Receives: Drug: Sym024
Sym024 Dose Level 2ExperimentalPart I, Sym024 monotherapy dose level 2
Receives: Drug: Sym024
Sym024 Dose Level 3ExperimentalPart I, Sym024 monotherapy dose level 3
Receives: Drug: Sym024
Sym024 Dose Level 4ExperimentalPart I, Sym024 monotherapy dose level 4
Receives: Drug: Sym024
Sym024 Dose Level -1ExperimentalPart I, Sym024 monotherapy dose level -1. Evaluate only if needed based on tolerability
Receives: Drug: Sym024
Sym021+Sym024 Dose Level 2ExperimentalPart II, Sym021 in combination with dose level 2 of Sym024
Receives: Drug: Sym021; Drug: Sym024
Sym021+Sym024 Dose Level 3ExperimentalPart II, Sym021 in combination with dose level 3 of Sym024
Receives: Drug: Sym021; Drug: Sym024
Sym021+Sym024 Dose Level 4ExperimentalPart II, Sym021 in combination with dose level 4 of Sym024
Receives: Drug: Sym021; Drug: Sym024
Sym021+Sym024 Dose Level 5ExperimentalPart IIa, Sym024 monotherapy and in combination with Sym021
Receives: Drug: Sym021; Drug: Sym024
Sym021+Sym024 Dose Level 1ExperimentalPart II, Sym021 in combination with dose level 1 of Sym024. Evaluate only if needed based on tolerability
Receives: Drug: Sym021; Drug: Sym024
Dose Expansion Sym021 (+Sym024)ExperimentalPart III, dose expansion Sym024 and/or Sym021+Sym024
Receives: Drug: Sym021; Drug: Sym024

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 12 months

Secondary outcomes (9)

  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

    Measured: 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)

    Measured: 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

    Measured: 24 months

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

    Will be estimated using non-compartmental methods and actual timepoints

    Measured: 24 months

  5. Maximum concentration (Cmax)

    Will be derived from observed data

    Measured: 24 months

  6. Time to reach maximum concentration (Tmax)

    Will be derived from observed data

    Measured: 24 months

  7. Trough concentration (Ctrough)

    Will be derived from observed data

    Measured: 24 months

  8. Terminal elimination half-life (T½)

    Will be estimated using non-compartmental methods and actual timepoints

    Measured: 24 months

  9. Clearance (CL)

    Will be estimated using non-compartmental methods and actual timepoints

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start19 Nov 2020
  3. Primary completion22 Nov 2024
  4. Study completion22 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04672434
Sponsor's protocol ID
Sym024-01
Status last verified
Dec 2024
First submitted
7 Dec 2020
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sym021 and Sym024 in people with Metastatic Cancer and Solid Tumor, run by Symphogen A/S at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I: To evaluate the incidence, severity and relationship of (S)AEs to establish the MTD/MAD of Sym024 monotherapy. (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04672434.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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