PF-07284892 in Participants With Advanced Solid Tumors

Overview

Información sobre este estudio

The purpose of this study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Age ≥18 years at the time of informed consent.

- Histological or cytological diagnosis of ALK-positive advanced NSCLC, CRC with BRAF
V600E mutation, or RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumor.
Participants with ROS-positive NSCLC are also eligible for Part 1 and 2.

- Documentation evidence of biomarker mutation status.

- Part 3:

ALK-positive NSCLC with prior lorlatinib and no prior platinum-based chemotherapy (Cohort
1); with prior lorlatinib and prior platinum-based chemotherapy (Cohort 2); or with no
prior lorlatinib (Cohort 3).

BRAF V600E mutant CRC participants resistant to BRAFi plus EGFRi (Cohort 4 ); refractory to
BRAFi plus EGFRi (Cohort 5); or BRAFi plus EGFRi naïve (Cohort 6).

RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior SOC
(Cohort 7).

Exclusion Criteria:

- Brain metastasis larger than 4 cm.

- Active malignancy within 3 years.

- Systemic anti-cancer therapy or small molecule therapeutics within 2 weeks prior to
start of study treatment. Antibody based agents within 4 weeks prior to start of study
treatment. Mitomycin C or nitrosoureas within 6 weeks prior to start of study
treatment.

- For participants who may get lorlatinib or encorafenib on study, history of
interstitial lung disease.

- For participants who may get binimetinib on study, history or current evidence of
retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with
elevated creatine kinase (CK).

Eligibility last updated 5/27/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Mojun Zhu, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Tanios Bekaii-Saab, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20538910

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