Phase 1
Completed N=24
Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
Source: ClinicalTrials.gov NCT03489343 ↗Enrolled (actual)
24
Serious AEs
16.7%
Results posted
Oct 2021
Primary outcomePrimary: Assessment of Treatment Emergent Adverse Events (AEs) Meeting Dose-limiting Toxicity (DLT) Criteria. — 0; 0; 0; 0 Number of DLTs
Summary
This was the first study to test Sym023 in humans. The primary purpose of this study was to see if Sym023 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Treatment Emergent Adverse Events (AEs) Meeting Dose-limiting Toxicity (DLT) Criteria. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Evaluation of the Immunogenicity of Sym023. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Evaluation of Objective Response (OR) or Stable Disease (SD) by RECIST v1.1 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Evaluation of Objective Response (OR) or Stable Disease (SD) by iRECIST |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Evaluation of Objective Response (OR) or Stable Disease (SD) by RECIL 2017. |
— | — |
| SECONDARY Time to Progression (TTP) of Disease. |
1.81; 7.89; 1.18; 3.48; 1.28; 1.68 | — |
| SECONDARY Area Under the Concentration-time Curve in a Dosing Interval (AUC). |
70; 176; 878; 3193; 8062; 30581 | — |
| SECONDARY Maximum Concentration (Cmax) |
0.85; 1.98; 7.94; 23.71; 68.03; 232.11 | — |
| SECONDARY Time to Reach Maximum Concentration (Tmax) |
4.5; 0.6; 1.2; 4.5; 1.8; 3.4 | — |
| SECONDARY Trough Concentration (Ctrough) |
NA; 0.16; 1.26; 6.39; 12.88; 74.33 | — |
| SECONDARY Terminal Elimination Half-life (T½) |
NA; 105.10; 153.49; 140.60; 185.22; 203.07 | — |
| SECONDARY Clearance (CL) |
0.501; 0.364; 0.582 | — |
Eligibility Criteria
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 ocular disease or condition, including history of autoimmune or inflammatory disorder.
- 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 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).
Data sourced from ClinicalTrials.gov (NCT03489343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.