Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

Summary

The purpose of this first-in-patient, open label 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.

Official Title

A Phase 1 Open-Label, Multi-Center, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PF-07284892 (ARRY-558) as a Single Agent and in Combination Therapy in Participants With Advanced Solid Tumors

Keywords

Solid Tumor colorectal cancer non-small cell lung cancer B-type Raf proto-oncogene (BRAF) mutation Ras mutation anaplastic lymphoma kinase (ALK)-positive neurofibromatosis type 1 (NF1) ROS1 Neoplasms Cetuximab lorlatinib binimetinib encorafenib PF-07284892 monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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).

You CAN'T join if...

  • 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)

Locations

  • UC Irvine Health accepting new patients
    Orange California 92868 United States
  • The University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT04800822
Phase
Phase 1
Study Type
Interventional
Last Updated