- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03489369
Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
1 febbraio 2021 aggiornato da: Symphogen A/S
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
15
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
-
-
-
-
Michigan
-
Grand Rapids, Michigan, Stati Uniti, 49503
- South Texas Accelerated Research Therapeutics (START) Midwest
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- The University of Texas MD Anderson Cancer Center
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Sym022
Sym022 will be administered at up to 4 planned dose levels.
|
Sym022 è un anticorpo ricombinante completamente umano che lega LAG-3 e blocca l'interazione LAG-3/complesso maggiore di istocompatibilità di classe II (MHC-II), consentendo così una maggiore proliferazione delle cellule T e la produzione di citochine.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Assessment of Treatment Related Adverse Events (AEs).
Lasso di tempo: 19 months
|
Assess the safety, tolerability and dose-limiting toxicities of Sym022 on a Q2W schedule to establish the MTD and/or RP2D.
|
19 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Evaluation of the Immunogenicity of Sym022.
Lasso di tempo: 19 months
|
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.
|
19 months
|
Evaluation of Objective Response (OR) or Stable Disease (SD).
Lasso di tempo: 13 months
|
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.
|
13 months
|
Time to Progression (TTP) of Disease.
Lasso di tempo: 13 months
|
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.
|
13 months
|
Area Under the Concentration-time Curve in a Dosing Interval (AUC).
Lasso di tempo: 19 months
|
Will be estimated using non-compartmental methods and actual timepoints.
|
19 months
|
Maximum Concentration (Cmax)
Lasso di tempo: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Will be derived from observed data.
|
0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Time to Reach Maximum Concentration (Tmax)
Lasso di tempo: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Will be derived from observed data.
|
0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Trough Concentration (Ctrough)
Lasso di tempo: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Will be derived from observed data.
|
0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Terminal Elimination Half-life (T½)
Lasso di tempo: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Will be estimated using non-compartmental methods and actual timepoints.
|
0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Clearance (CL)
Lasso di tempo: 0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Will be estimated using non-compartmental methods and actual timepoints.
|
0, 2, 4, 8, 24, 48, 168 hours and 336 hours as administered Q2W (every second week)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Lillian Siu, MD, FRCPC, Princess Margaret Cancer Centre
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 maggio 2018
Completamento primario (Effettivo)
6 gennaio 2020
Completamento dello studio (Effettivo)
6 gennaio 2020
Date di iscrizione allo studio
Primo inviato
26 marzo 2018
Primo inviato che soddisfa i criteri di controllo qualità
3 aprile 2018
Primo Inserito (Effettivo)
5 aprile 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 febbraio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 febbraio 2021
Ultimo verificato
1 febbraio 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Sym022-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Sym022
-
Symphogen A/SCompletatoLinfoma | Tumore solido | Cancro metastaticoCanada, Stati Uniti
-
Symphogen A/SAttivo, non reclutanteTumore solido | Cancro metastaticoStati Uniti, Canada, Francia, Spagna