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NCT Number: NCT05538130

A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors

The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).

Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have:

* a solid tumor which is metastatic or recurrent (excluding colorectal cancer) * tumor with the mutation (abnormal gene) called "BRAF V600" * received required prior treatment for cancer per cohort assigned.

All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.

Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.

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Key information

Conditions

Melanoma Advanced or Metastatic Solid Tumors Brain Diseases Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Differentiated Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Glioma HGG Head and Neck Neoplasms High Grade Glioma LGG Low Grade Glioma Lung Diseases Lung Neoplasms Malignant Neoplasms NSCLC (Non-small Cell Lung Cancer) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Phase 1b Inclusion Criteria:

  • Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer)
  • Measurable disease by RECIST version 1.1
  • Evidence of a BRAF V600 mutation
  • Prior therapy per tumor cohort
  • Adequate organ function per protocol

Phase 1b Exclusion Criteria:

  • Other active malignancy within 3 years
  • Presence of leptomeningeal disease
  • History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease
  • Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
  • Active gastrointestinal disease as defined per protocol
  • History of interstitial lung disease as defined per protocol

Treatment and study plan

PF-07799544

Drug

Tablet

Other names: ARRY-134

PF-07799933

Drug

Tablet

Other names: ARRY-440

Primary outcomes

  1. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs)

    Time frame: Cycle 1 (21 days)

    DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)

  2. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs)

    Time frame: Baseline to 28 days after last dose of study medication

    AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy

  3. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities

    Time frame: Baseline to 28 days after last dose of study treatment

    Laboratory abnormalities as characterized by type, frequency, severity, and timing.

  4. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities

    Time frame: Baseline to 28 days after last dose of study treatment

    Vital sign abnormalities as characterized by type, frequency, severity, and timing.

  5. Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities

    Time frame: Baseline to 28 days after last dose of study treatment

    Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  6. Phase 1b Dose Expansion: Overall response rate (ORR)

    Time frame: Baseline to 2 years

    Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors

Secondary outcomes

  1. Phase 1a monotherapy and Phase 1b combination dose escalation: ORR

    Time frame: Baseline to 2 years

    ORR as assessed using the RECIST version 1.1.

  2. Phase 1b Dose Expansion: Number of participants with treatment-emergent adverse events (AEs)

    Time frame: Baseline to 2 years

    AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy

  3. Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in vital sign abnormalities

    Time frame: Baseline to 2 years

    Vital sign abnormalities as characterized by type, frequency, severity, and timing.

  4. Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in laboratory abnormalities

    Time frame: Baseline to 2 years

    Laboratory abnormalities as characterized by type, frequency, severity, and timing.

  5. Phase 1b Dose Expansion: Duration of Response (Overall and in CNS)

    Time frame: Baseline to 2 years

    Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors

  6. Phase 1b Dose Expansion: Intracranial response

    Time frame: Baseline to 2 years

    Intracranial response by RECIST version 1.1 (for brain metastases)

  7. Phase 1b Dose Expansion: Progression Free Survival (PFS)

    Time frame: Baseline to 2 years

    Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors

  8. PK Parameters: Maximum Observed Concentration (Cmax)

    Time frame: Baseline to 2 years

    Single dose and multiple dose PK will be calculated as data permits

  9. PK Parameters: Maximum Plasma Concentration (Tmax)

    Time frame: Baseline to 2 years

    Single dose and multiple dose PK will be calculated as data permits

  10. PK Parameters: Area Under Curve (AUC)

    Time frame: Baseline to 2 years

    Single dose and multiple dose PK will be calculated as data permits

  11. PK Parameters: terminal elimination half-life (t½)

    Time frame: Baseline to 2 years

    Singe dose and multiple dose PK will be calculated as data permits

  12. PK Parameters: Apparent Oral Clearance (CL/F)

    Time frame: Baseline to 2 years

    Singe dose and multiple dose PK will be calculated as data permits

  13. PK Parameters: Apparent Volume of Distribution (Vz/F)

    Time frame: Baseline to 2 years

    Singe dose and multiple dose PK will be calculated as data permits

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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 BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Sep 13, 2022
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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