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PF-07284892 in Participants With Advanced Solid Tumors

NCT ID: NCT04800822

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2024-06-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-07284892 monotherapy

Monotherapy dose escalation of PF-07284892 in participants with ALK- or ROS1-positive non-small cell lung cancer (NSCLC), B-type Raf proto-oncogene V600E mutation colorectal cancer (CRC), or RAS- mutant, NF1-mutant or BRAF class 3-mutant solid tumors

Group Type EXPERIMENTAL

PF-07284892

Intervention Type DRUG

PF-07284892

PF-07284892 in combination with lorlatinib (Part 2)

Combination dose escalation of PF-07284892 in combination with lorlatinib in participants with ALK- or ROS1-positive NSCLC

Group Type EXPERIMENTAL

PF-07284892

Intervention Type DRUG

PF-07284892

lorlatinib

Intervention Type DRUG

lorlatinib

Expansion Phase (Cohort 1)

PF-07284892 + lorlatinib in participants with ALK+ NSCLC with prior lorlatinib

Group Type EXPERIMENTAL

PF-07284892

Intervention Type DRUG

PF-07284892

lorlatinib

Intervention Type DRUG

lorlatinib

Expansion Phase (Cohort 2)

PF-07284892 + lorlatinib in participants with ALK+ NSCLC with no prior lorlatinib

Group Type EXPERIMENTAL

PF-07284892

Intervention Type DRUG

PF-07284892

lorlatinib

Intervention Type DRUG

lorlatinib

Expansion Phase (Cohort 3)

PF-07284892 + encorafenib + cetuximab in participants with BRAF V600E mutant CRC with prior BRAF inhibitor (BRAFi) plus epidermal growth factor receptor inhibitor (EGFRi)

Group Type EXPERIMENTAL

PF-07284892

Intervention Type DRUG

PF-07284892

cetuximab

Intervention Type BIOLOGICAL

cetuximab

encorafenib

Intervention Type DRUG

encorafenib

Expansion Phase (Cohort 4)

PF-07284892 + encorafenib + cetuximab in participants with BRAF V600E mutant CRC with no prior BRAFi plus EGFRi

Group Type EXPERIMENTAL

PF-07284892

Intervention Type DRUG

PF-07284892

cetuximab

Intervention Type BIOLOGICAL

cetuximab

encorafenib

Intervention Type DRUG

encorafenib

Expansion Phase (Cohort 5)

PF-07284892 + binimetinib in participants with RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior standard of care (SOC)

Group Type EXPERIMENTAL

PF-07284892

Intervention Type DRUG

PF-07284892

binimetinib

Intervention Type DRUG

binimetinib

PF-07284892 in combination with encorafenib and cetuximab (Part 2)

Combination dose escalation of PF-07284892 in combination with encorafenib and cetuximab in participants with BRAF V600E mutant CRC

Group Type EXPERIMENTAL

PF-07284892

Intervention Type DRUG

PF-07284892

cetuximab

Intervention Type BIOLOGICAL

cetuximab

encorafenib

Intervention Type DRUG

encorafenib

PF-07284892 in combination with binimetinib (Part 2)

Combination dose escalation of PF-07284892 in combination with binimetinib in participants with Ras-mutant, NF-1 mutant or BRAF class 3 -mutant solid tumors

Group Type EXPERIMENTAL

PF-07284892

Intervention Type DRUG

PF-07284892

binimetinib

Intervention Type DRUG

binimetinib

Interventions

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PF-07284892

PF-07284892

Intervention Type DRUG

lorlatinib

lorlatinib

Intervention Type DRUG

binimetinib

binimetinib

Intervention Type DRUG

cetuximab

cetuximab

Intervention Type BIOLOGICAL

encorafenib

encorafenib

Intervention Type DRUG

Other Intervention Names

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ARRY-558 Lorbrena; PF-06463922, Lorviqua Mektovi, PF-06811462, MEK162 Erbitux Braftovi, PF-07263896, LGX818

Eligibility Criteria

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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 (Other ROS1-positive solid tumors may be considered after discussion with the sponsor).
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

Site Status

Mayo Clinic

Scottsdale, Arizona, United States

Site Status

California Cancer Associates for Research and Excellence

Encinitas, California, United States

Site Status

California Cancer Associates for Research and Excellence

San Marcos, California, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Brigitte Harris Cancer Pavilion

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

START Midwest

Grand Rapids, Michigan, United States

Site Status

Henry Ford Medical Center - Columbus

Novi, Michigan, United States

Site Status

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Site Status

Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavilion

New York, New York, United States

Site Status

Tennessee Oncology PLLC

Franklin, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Franklin, Tennessee, United States

Site Status

Sarah Cannon Research Institute- Pharmacy

Nashville, Tennessee, United States

Site Status

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status

Tennessee Oncology PLLC

Nashville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4481001

To obtain contact information for a study center near you, click here.

Other Identifiers

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2022-502431-18-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-003166-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SHP2

Identifier Type: OTHER

Identifier Source: secondary_id

C4481001

Identifier Type: -

Identifier Source: org_study_id

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