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

NCT03489369 | Completed Phase 1 Results FDA Drug

• 1 other identifier: Sym022-01
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Metastatic Cancer; Solid Tumor; Lymphoma

Keywords

Locally advanced/unresectable; Metastatic solid tumor; Lymphoma; Anti-LAG-3; LAG-3; LAG3

Outcome Measures

Primary Outcomes (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.

  19 months

Secondary Outcomes (9)

• Evaluation of the Immunogenicity of Sym022.

  19 months

• Evaluation of Objective Response (OR) or Stable Disease (SD).

  13 months

• Time to Progression (TTP) of Disease.

  13 months

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

  19 months

• Maximum Concentration (Cmax)

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

Study Arms (1)

Sym022

EXPERIMENTAL

Sym022 will be administered at up to 4 planned dose levels.

Drug: Sym022

Interventions

Sym022 DRUG

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.

Also known as: Anti-LAG-3

Sym022

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Symphogen A/S: lead

Study Sites (3)

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, 49503, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Lymphoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Symphogen AS

info@symphogen.com

004545265050

Study Officials

• Lillian Siu, MD, FRCPC

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 5, 2018
• Study Start: May 8, 2018
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: February 18, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)