Patologia: Tumori delle vie biliari, Altre neoplasie
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: 1, II
Linee di trattamento: Prima linea, Seconda linea
Criteri di inclusione:
- Histologically or cytologically confirmed unresectable or metastatic solid tumor
- Documented FGFR2 gene fusion, mutation, or amplification per local testing of blood and/or tumor
- Patient must have measurable disease per RECIST v1.1
- Patient has ECOG performance status of 0-1
- Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy.
- Part 2 dose expansion patients with Cholangiocarcinoma:
- Group 1: CCA patients with an FGFR2 fusion previously treated with an FGFRi
- Group 2: CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi
- Group 6: CCA patients with an FGFR2 fusion with no prior chemotherapy and not previously treated with an FGFRi. Prior adjuvant/neo-adjuvant treatment completed >6 months before enrollment is acceptable. Up to 2 cycles of palliative chemotherapy are allowed during screening
- Group 7: CCA patients with an FGFR2 mutation or amplification and not previously treated with an FGFRi
- Part 2 dose expansion patients with other solid tumors (NOT Cholangiocarcinoma):
- Group 3: Non-CCA patients with an FGFR2 fusion and not previously treated with an FGFRi
- Group 4: Non-CCA patients with an FGFR2 amplification and not previously treated with an FGFRi
- Group 5: Non-CCA patients with an FGFR2 mutation and not previously treated with an FGFRi
- Part 3 extension:
- CCA patients with an FGFR2 fusion with prior chemotherapy but not previously treated with an FGFRi.
Criteri di esclusione:
- Ongoing, clinically significant FGFRi-induced retinal detachment or an ongoing clinically significant corneal or retinal disorder
- Patient does not have adequate organ function (defined in protocol)
- Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol).
- QT interval corrected using Fridericia's formula (QTcF) > 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome
- Clinically significant, uncontrolled cardiovascular disease
- CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.
Trattamento sperimentale:
RLY-4008
Trattamento di controllo:
NA
Obiettivi primari dello studio:
- Part 1: Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-4008 [ Time Frame: Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months ]
- Part 1: Number of patients with adverse events and serious adverse events [ Time Frame: Every cycle (4-week cycles) until study discontinuation, approximately 24 months ]
- Part 2 and Part 3: Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1 [ Time Frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months ].
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Riferimento: Prof. Federico Capuuzzo
Telefono: 0652665698
Email: federico.cappuzzo@ifo.it
Numero di iscrizione a registro: NCT04526106 - 2020-004535-24
Data di inserimento: 12.06.2023
Relay Therapeutics, Inc
Istituto Europeo di Oncologia
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
Localita: Milano