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

Symphogen

Status and phase

Completed

Phase 1

Conditions

Solid Tumor

Metastatic Cancer

Lymphoma

Treatments

Drug: Sym022

Study type

Interventional

Funder types

Industry

Identifiers

NCT03489369

Sym022-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
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