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Metastatic CancerPhase 1NCT03489369

Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas

A Phase 1 study testing Sym022 in people with Metastatic Cancer and Solid Tumor, run by Symphogen A/S at 3 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

This is the first study to test Sym022 in humans. The primary purpose of this study is to see if Sym022 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer, Solid Tumor, Lymphoma
What is being tested?
Sym022
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesin 2 countries
Study dates
8 May 2018to 6 Jan 2020
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 of age at the time of obtaining informed consent.
  • Documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; patients with documented lymphomas.
  • Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or nonresectability of the tumor.
  • Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit.
  • Measurable or non-measurable disease according to RECIST v1.1 or RECIL 2017.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug.

Who cannot join

  • Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a highly effective method of contraception.
  • Known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression, patients with any of the above not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
  • Hematologic malignancies other than lymphomas.
  • Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to Cycle 1/Day 1 (C1/D1) unless adequately treated and considered stable
  • Active uncontrolled bleeding or a known bleeding diathesis
  • Clinically significant cardiovascular disease or condition
Show all 21Show fewer
  • Significant pulmonary disease or condition
  • Current or recent (within 6 months) significant gastrointestinal (GI) disease or condition.
  • An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
  • History of organ transplantation (e.g. stem cell or solid organ transplant)
  • History of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapy
  • Patients with unresolved > Grade 1 toxicity associated with any prior antineoplastic therapy, with exceptions.
  • Inadequate recovery from any prior surgical procedure, or having undergone any major surgical procedure within 4 weeks prior to C1/D1.
  • Known history of human immunodeficiency virus (HIV) or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Other Inhibitors of LAG-3
  • Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest, prior to first administration of study drug and during study
  • Any other investigational treatments within 4 weeks prior to and during study
  • Radiotherapy for target lesions within 4 weeks prior to first administration of study drug unless PD has been documented in the lesion following treatment, and during study.
  • Radiotherapy for non-target lesions within 1 week prior to first administration of study drug
  • Immunosuppressive or systemic hormonal therapy
  • Prophylactic use of hematopoietic growth factors within 1 week prior to first administration of study drug and during Cycle 1 of study

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • South Texas Accelerated Research Therapeutics (START) Midwest

    Grand Rapids, Michigan, 49503

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

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 Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas

This is the first study to test Sym022 in humans. The primary purpose of this study is to see if Sym022 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.

Read the detailed description

This study will evaluate the preliminary safety, tolerability, and dose-limiting toxicities (DLTs) of Sym022, an anti-lymphocyte activation gene 3 (anti-LAG-3) monoclonal antibody (mAb). The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of Sym022 when administered once every 2 weeks (Q2W) by intravenous (IV) infusion to patient cohorts with locally advanced/ unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available. If an MTD is not identified, a maximum administered dose (MAD) will be determined. Sym022 will be given to patients in escalating dose cohorts; each patient will be given one fixed dose level.

Being tested
Sym022
Keywords
Locally advanced/unresectable, Metastatic solid tumor, Lymphoma, Anti-LAG-3, LAG-3, LAG3
Medical subject headings
Neoplasm Metastasis, Lymphoma

What participants receive

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

  • Sym022Drug

    Also called Anti-LAG-3

    Sym022 is a recombinant, fully human antibody that binds LAG-3 and blocks the LAG-3/major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production.

Study groups in NCT03489369
Study groupRoleWhat they receive
Sym022ExperimentalSym022 will be administered at up to 4 planned dose levels.
Receives: Drug: Sym022

What is being measured

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

  1. Assessment of Treatment Related Adverse Events (AEs).

    Assess the safety, tolerability and dose-limiting toxicities of Sym022 on a Q2W schedule to establish the MTD and/or RP2D.

    Measured: 19 months

Secondary outcomes (9)

  1. Evaluation of the Immunogenicity of Sym022.

    Serum sampling and incidence (%) per dose level to assess the potential for anti-drug antibody (ADA) formation. Count of participants show the number of participants who were tested positive for anti-Sym022 ADA.

    Measured: 19 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), Response Evaluation Criteria in Lymphomas 2017 (RECIL 2017), or Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST), depending on tumor type. The numbers shown below correspond to the values related to RECIST v1.1.

    Measured: 13 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, RECIL 2017, or iRECIST, depending on tumor type. The numbers shown below correspond to the values related to RECIST v1.1.

    Measured: 13 months

  4. Area Under the Concentration-time Curve in a Dosing Interval (AUC).

    Will be estimated using non-compartmental methods and actual timepoints.

    Measured: 19 months

  5. Maximum Concentration (Cmax)

    Will be derived from observed data.

    Measured: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)

  6. Time to Reach Maximum Concentration (Tmax)

    Will be derived from observed data.

    Measured: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)

  7. Trough Concentration (Ctrough)

    Will be derived from observed data.

    Measured: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)

  8. Terminal Elimination Half-life (T½)

    Will be estimated using non-compartmental methods and actual timepoints.

    Measured: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)

  9. Clearance (CL)

    Will be estimated using non-compartmental methods and actual timepoints.

    Measured: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)

Timeline

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

  1. First posted5 Apr 2018
  2. Study start8 May 2018
  3. Primary completion6 Jan 2020
  4. Study completion6 Jan 2020

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03489369
Sponsor's protocol ID
Sym022-01
Status last verified
Feb 2021
First submitted
26 Mar 2018
Last updated
18 Feb 2021
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 Sym022 in people with Metastatic Cancer and Solid Tumor, run by Symphogen A/S at 3 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 7 inclusion and 21 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Assessment of Treatment Related Adverse Events (AEs). (time frame: 19 months). 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 NCT03489369.

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 18 Feb 2021.

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