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A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 in Patients With Advanced Solid Tumors - INCMGA0012-101

Studio Clinico

Patologia: Tumori dell’utero, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I,

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea, Seconda linea, Terza/N linea

Criteri di inclusione: 

- Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined. Patients enrolled to Cohort H (endometrial cancer 500 mg Q4W) must have MSI-H or dMMR endometrial cancer, as determined by a local laboratory using IHC or PCR methods and must also have tissue (fresh or archival) available for central confirmation of diagnosis
- Expansion cohort(s): Progression during or following at least 1, and up to 5, previous systemic therapies, consistent with the standard of care for the specific tumor type.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥ 12 weeks
- Measurable disease
- Acceptable laboratory parameters

Criteri di esclusione: 

- Symptomatic central nervous system (CNS) metastases.
- For Cohort Expansion, patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) are not eligible for this study.
- Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
- Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 4 weeks prior to the initiation of study drug administration.
- Treatment with radiation therapy within 2 weeks prior to the initiation of study drug administration.
- Clinically significant cardiovascular disease
- Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
- Presence of active pneumonitis or history of non-infectious pneumonitis.
- Clinically significant gastrointestinal disorders
- Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug
- Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
- Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR)
- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed
- Dementia or altered mental status that would preclude understanding and rendering of informed consent

Schema di trattamento: 

Dose Escalation-Q2W
INCMGA00012 treatment once every 2 weeks.

Dose Escalation- Q3W
INCMGA00012 treatment once every 3 weeks.

Dose Escalation- Q4W
INCMGA00012 treatment once every 4 weeks.

Expansion Cohort
INCMGA00012 treatment for locally advanced or metastatic solid tumors.

Trattamento sperimentale: 

INCMGA00012

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 [ Time Frame: 24 months ]
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.

- MTD [ Time Frame: 24 months ]
Maximum Tolerated Dose of INCMGA00012

Centri partecipanti

Nord Italia

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

Riferimento: Dr. Giorgio Valabrega
Telefono: 0119933250
Email: giorgio.valabrega@ircc.it

 

Centro Italia

Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN

Riferimento: Prof.ssa Rossana Berardi
Telefono: 0715965715
Email: r.berardi@univpm.it

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Riferimento: Dr.ssa Domenica Lorusso
Telefono: 0630158545
Email: domenica.lorusso@policlinicogemelli.it

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Riferimento: Dr. Daniele

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03059823

Data di inserimento: 22.03.2019

Promotore

Incyte Corporation

CRO

na

Principal Investigator ITALIA

Fondazione Policlinico Universitario A. Gemelli, Roma

Riferimento: Dr.ssa Domenica Lorusso

Telefono: 0630158545

Email: domenica.lorusso@policlinicogemelli.it

Localita: Roma

 

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