C4201002 - ARRAY-067-102 - A phase I, open-label, multi-center, dose-finding, pharmacokinetic, safety and tolerability study of PF-07265807 in participants with selected advanced or metastatic solid tumor malignancies

Studio Clinico

Patologia: Neoplasie del polmone, Neoplasie dello stomaco, Tumori del colon retto, Tumori del rene, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1,

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Male or female participants ≥ 18 years
- At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), not previously irradiated, as defined by RECIST 1.1
- ECOG Performance Status 0 or 1, 2 with approval
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
- Resolved acute effects of any prior therapy
- Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some participants will require mandatory pre- and on-treatment biopsy is part of the biomarker cohort).
- Life expectancy of at least 3 months.
- Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment for selected solid tumors.
- Part 3: Participants with advanced/metastatic RCC with a clear cell component and progressed with no standard therapy available.
- Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy.
- Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with no satisfactory alternative treatment available, but has not received prior treatment with an anti-PD-(L)1 therapy.
- Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy regiments, but has not received prior treatment with an anti-PD-(L)1 therapy.
- Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with IMDC intermediate or poor risk that have not received any prior systemic therapy for metastatic disease.

Criteri di esclusione: 

- Known active uncontrolled or symptomatic CNS metastases.
- Any other active malignancy within 2 years prior to enrollment.
- Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer therapy within 2 week or 5 half-lives (4 - weeks or 5 half-lives for antibody therapies or investigational drug(s) taken on another study) prior to study entry.
- Active or history of autoimmune disease requiring >10mg/day prednisone or other concurrent immunosuppressive therapy.
- Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as defined in protocol.
- Retinal or other serious ophthalmic disorders as defined in protocol.
- Clinically significant cardiac disease as defined in protocol.
- Uncontrolled HTN that cannot be controlled by medications.
- Inability to consume or absorb study drug.
- Known or suspected hypersensitivity to PF-07265807.
- Prohibited concomitant medications as defined in protocol.
- Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric resection or lap band surgery affecting absorption.
- Active bleeding disorder.
For Part 2, Part 3, and Part 4, Cohorts 2-4:
- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.
- Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.
- Experienced >= G3 treatment-related irAE with prior PD-(L)1 agent.

Numero di pazienti previsti: 

6 (in Italia)

Schema di trattamento: 

Part 1: Monotherapy dose escalation of PF-07265807 in participants with select tumor types.
Part 2: PF-07265807 + sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.
Part 3: PF-07265807 + sasanlimab + axitinib in participants with RCC. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.
Part 4, Cohort 1: PF-07265807 in participants with METex14 mutant NSCLC.
Part 4, Cohort 2: PF-07265807 with sasanlimab in participants with MSS CRC
Part 4, Cohort 3: PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ
Part 4, Cohort 4: PF-07265807 with sasanlimab plus axitinib in participants with RCC.

Trattamento sperimentale: 

PF-07265807
Sasanlimab
Axitinib

Trattamento di controllo: 

NA

Data di inizio dell'arruolamento: 15.04.2022

Data di fine dell'arruolamento: 07.04.2023

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-004270-59

Data di inserimento: 19.01.2023

Promotore

Pfizer

CRO

PPD

Principal Investigator ITALIA

IEO - Istituto Europeo di Oncologia, Milano

Riferimento: Prof. Giuseppe Curigliano

Telefono: 0257489599

Email: giuseppe.curigliano@ieo.it

Localita: Milano