A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

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Active drug More information High burden on patient More information

Trial Details

Sponsor: Pfizer (industry)

Phase: 1

Start date: Nov. 30, 2022

Planned enrollment: 124

Trial ID: NCT05538130
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: PF-07799933 (ARRY-440)

chevron Show for: PF-07799544 (ARRY-134)

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Goal: To assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of PF-07799544, a novel brain-penetrant MEK inhibitor, as monotherapy and in combination with other targeted agents in patients with advanced solid tumors, including subsets of patients with BRAF mutations.

Patients: Adults with advanced or metastatic solid tumors, including primary brain tumors, who have progressed on standard treatments or have no satisfactory alternative options. Specific expansion cohorts include patients with melanoma harboring BRAF V600 or non-V600 class II/III alterations, and other solid tumors with BRAF class II/III mutations.

Design: This is a non-randomized, open-label, multi-arm phase 1 trial with both dose escalation and expansion cohorts. Participants receive either PF-07799544 alone or in combination with other investigational agents, with allocation depending on tumor type and molecular alterations.

Treatments: The study evaluates PF-07799544, an oral, brain-penetrant MEK inhibitor with preclinical and early-phase evidence of activity against tumors with alterations in the RAS/RAF/MEK/ERK pathway. PF-07799544 specifically targets MEK and is administered as a tablet, initially twice daily. In combination arms, the study also investigates PF-07799933, a brain-penetrant, selective pan-mutant BRAF inhibitor with activity against all classes of BRAF mutations. No definitive human efficacy data for PF-07799544 exist yet, though its ability to penetrate the CNS is of particular interest, especially for tumors with brain involvement. Encorafenib, a standard oral BRAF inhibitor, is also used in certain arms, specifically in patients with melanoma.

Outcomes: Primary endpoints include assessment of dose-limiting toxicities, adverse events (AEs), laboratory and vital sign abnormalities, and overall response rate (ORR, by RECIST v1.1) in dose expansion cohorts. Secondary endpoints include PK parameters for both PF-07799544 and PF-07799933, further safety measures, duration of response (including intracranial responses), and progression-free survival.

Burden on patient: Patient burden is expected to be high, typical for a phase 1 trial. Participants will undergo frequent clinic visits for safety assessments, laboratory tests, pharmacokinetic blood sampling, and radiographic tumor evaluations. Participation may also require tumor biopsies for molecular characterization or response assessment. The necessity for protocol-specific PK sampling and possibly additional scans, particularly for assessment of brain metastases, increases visit frequency and blood loss compared to standard care.

Eligibility More information

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Sites (48)

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Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

No email / No phone

Status: Recruiting

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

No email / No phone

Status: Recruiting

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

No email / No phone

Status: Recruiting

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

No email / No phone

Status: Recruiting

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

No email / No phone

Status: Recruiting

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus

Quebec City, Quebec, G1J 1Z4, Canada

No email / No phone

Status: Recruiting

McGill University Health Centre

Montréal, Quebec, H4A 3J1, Canada

No email / No phone

Status: Recruiting

Soroka Medical Center

Beer-Sheva, Hadarom, 8410101, Israel

No email / No phone

Status: Recruiting

Sheba Medical Center

Ramat Gan, Hamerkaz, 5265601, Israel

No email / No phone

Status: Recruiting

Rabin Medical Center

Petah Tikva, Hamerkaz, 4941492, Israel

No email / No phone

Status: Recruiting

Sourasky Medical Center

Tel Aviv, Tell Abīb, 6423906, Israel

No email / No phone

Status: Recruiting

Hadassah Medical Center

Jerusalem, Yerushalayim, 9112001, Israel

No email / No phone

Status: Not yet recruiting

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

No email / No phone

Status: Recruiting

Highlands Oncology Group, PA

Springdale, Arkansas, 72762, United States

No email / No phone

Status: Recruiting

The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate

Los Angeles, California, 90025, United States

No email / No phone

Status: Not yet recruiting

The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)

Santa Monica, California, 90404, United States

No email / No phone

Status: Not yet recruiting

Moffitt Cancer Center

Tampa, Florida, 33612, United States

No email / No phone

Status: Recruiting

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

Tampa, Florida, 33612, United States

No email / No phone

Status: Recruiting

Moffitt McKinley Hospital

Tampa, Florida, 33612, United States

No email / No phone

Status: Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Recruiting

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

No email / No phone

Status: Recruiting

Henry Ford Hospital

Detroit, Michigan, 48202, United States

No email / No phone

Status: Recruiting

Brigitte Harris Cancer Pavilion

Detroit, Michigan, 48202, United States

No email / No phone

Status: Recruiting

MSK Basking Ridge.

Basking Ridge, New Jersey, 07920, United States

No email / No phone

Status: Recruiting

MSK Monmouth.

Middletown, New Jersey, 07748, United States

No email / No phone

Status: Recruiting

MSK Bergen.

Montvale, New Jersey, 07645, United States

No email / No phone

Status: Recruiting

Columbia University Irving Medical Center

New York, New York, 10032, United States

No email / No phone

Status: Recruiting

Columbia University Medical Center - Neurological Institute of New York

New York, New York, 10032, United States

No email / No phone

Status: Recruiting

CUIMC Research Pharmacy

New York, New York, 10032, United States

No email / No phone

Status: Recruiting

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065, United States

No email / No phone

Status: Recruiting

Brooklyn Radiation Oncology, PC

Richmond Hill, New York, 11418, United States

No email / No phone

Status: Not yet recruiting

MSK Nassau.

Uniondale, New York, 11553, United States

No email / No phone

Status: Recruiting

Clinical Research Alliance

Westbury, New York, 11590, United States

No email / No phone

Status: Not yet recruiting

Memorial Sloan Kettering Cancer Center 53rd street.

New York, New York, 10022, United States

No email / No phone

Status: Recruiting

MSK Westchester.

Harrison, New York, 10604, United States

No email / No phone

Status: Recruiting

MSK Commack.

Commack, New York, 11725, United States

No email / No phone

Status: Recruiting

Optum Medical Care, PC

Brewster, New York, 10509, United States

No email / No phone

Status: Not yet recruiting

Cleveland Clinic Taussig Cancer Center Investigational Pharmacy

Cleveland, Ohio, 44106, United States

No email / No phone

Status: Recruiting

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

No email / No phone

Status: Recruiting

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213, United States

No email / No phone

Status: Recruiting

Providence Portland Medical Center

Portland, Oregon, 97213, United States

No email / No phone

Status: Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

Sarah Cannon Research Institute- Pharmacy

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

University of Washington Medical Center

Seattle, Washington, 98195, United States

No email / No phone

Status: Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

No email / No phone

Status: Recruiting

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