Patologia: Carcinoma della vescica, Neoplasie della mammella, Neoplasie del polmone, Tumori dell’utero, Tumori della testa e del collo, Altre neoplasie
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: 1, II
Linee di trattamento: Non applicabile
Criteri di inclusione:
For Dose Escalation:
- Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy
For Expansion:
- Have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for standard therapy
For Both Dose Escalation and Expansion:
- Have measurable disease according to RECIST 1.1
- Have Eastern Cooperative Oncology Group (ECOG) 0-1
- Have an acceptable hematological status
- Have acceptable liver function
- Have an acceptable coagulation status
- Have acceptable renal function
Criteri di esclusione:
- Have uncontrolled intercurrent illness, including but not limited to:
- Ongoing or active infection requiring intravenous treatment with antiinfective therapy
- Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia
- Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management
- Ongoing or recent evidence of autoimmune disease
- History of irAEs that led to prior checkpoint treatment discontinuation
- Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade
- History of chronic liver disease or evidence of hepatic cirrhosis
- History of non-infectious pneumonitis that has required steroids or currently has pneumonitis
- History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1046
- Serious, non-healing wound, skin ulcer (of any grade), or bone fracture
- Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
- Prior therapy:
- Radiotherapy: Radiotherapy within 14 days prior to first GEN1046 administration. Palliative radiotherapy will be allowed.
- Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1046 administration. Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid, etc.) and denosumab
- Toxicities from previous anti-cancer therapies that have not adequately resolved.
Schema di trattamento:
GEN1046 will be administered intravenously once every 21 days.
GEN1046 in combination with docetaxel (in a single expansion cohort) will be administered intravenously once every 21 days.
Trattamento sperimentale:
GEN1046
Trattamento di controllo:
NA
Obiettivi primari dello studio:
- Dose limiting toxicity (DLT) [ Time Frame: DLTs are assessed during the first cycle (21 days) in each cohort] ]
to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
- Adverse events [ Time Frame: AEs are collected throughout the study and up to 2 months after last subject last treatment ]
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
- Safety laboratory parameters (hematology, biochemistry, coagulation, endocrines) [ Time Frame: Safety laboratory data are collected throughout the study and up to 2 months after last subject last treatment ]
Laboratory parameters graded by CTCAE v5.0
Note generali:
Linea di trattamento: metastatica
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
Riferimento: Dr. Paolo A. Ascierto
Telefono: 0815903236
Email: p.ascierto@istitutotumori.na.it
Numero di iscrizione a registro: 2018-003402-63
Data di inserimento: 28.07.2021
Genmab
Istituto Nazionale Tumori IRCCS - Fondazione Pascale, Napoli
Riferimento: Dr. Paolo A. Ascierto
Telefono: 0815903236
Email: p.ascierto@istitutotumori.na.it
Localita: Napoli