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

NCT05538130
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
148
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Lead sponsor
Pfizer
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Start date
2022-11-30
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Number of sites
66
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Summary
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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Short title
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
clinicaltrials.gov
Official 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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-08-31
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First posted
2022-09-13
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Registry last updated
2026-09-01
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Primary completion date
2027-08-31
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Start date
2022-11-30
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Actual participants
148
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Participants
148
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
66
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05538130
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ClinicalTrials.gov ID
NCT05538130
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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

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

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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

    Timeframe: Baseline to 2 years

    Intracranial response by RECIST version 1.1 (for brain metastases)

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

    Timeframe: 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)

    Timeframe: Baseline to 2 years

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

  9. PK Parameters: Maximum Plasma Concentration (Tmax)

    Timeframe: Baseline to 2 years

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

  10. PK Parameters: Area Under Curve (AUC)

    Timeframe: Baseline to 2 years

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

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

    Timeframe: Baseline to 2 years

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

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

    Timeframe: 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)

    Timeframe: Baseline to 2 years

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
16 Years
Healthy volunteers
No

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
Sources for eligibility
clinicaltrials.gov

Sex
All
Minimum age (years)
16
Healthy volunteers
No

Adults with advanced/metastatic solid tumors (excluding colorectal cancer) having measurable disease and BRAF V600 mutation

  • 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

  • Other active malignancy within 3 years

  • Presence of leptomeningeal disease

  • History or current evidence of retinal vein occlusion (RVO)

  • History of retinal degenerative disease

    Source text: 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

  • The Kirklin Clinic of UAB HospitalBirmingham, United States
  • The University of Alabama at BirminghamBirmingham, United States
  • University of Alabama at Birmingham - Phase I Clinical Trials UnitBirmingham, United States
  • Highlands Oncology Group, PAFayetteville, United States
  • Highlands Oncology Group, PARogers, United States
  • Highlands Oncology Group, PASpringdale, United States
  • The Angeles Clinic and Research Institute- A Cedars-Sinai AffiliateLos Angeles, United States
  • Keck Hospital of USCLos Angeles, United States
  • Los Angeles General Medical CenterLos Angeles, United States
  • USC/Norris Comprehensive Cancer CenterLos Angeles, United States
  • Keck Medical Center of USC PasadenaPasadena, United States
  • UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United States
  • UCSF Helen Diller Medical Center at Parnassus HeightsSan Francisco, United States
  • UCSF Medical Center, Investigational PharmacySan Francisco, United States
  • The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)Santa Monica, United States
  • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient CenterTampa, United States
  • Moffitt Cancer CenterTampa, United States
  • Moffitt McKinley HospitalTampa, United States
  • Ochsner Clinic FoundationNew Orleans, United States
  • Brigham and Women's HospitalBoston, United States
  • Dana-Farber Cancer InstituteBoston, United States
  • Brigitte Harris Cancer PavilionDetroit, United States
  • Henry Ford HospitalDetroit, United States
  • MSK Basking Ridge.Basking Ridge, United States
  • MSK Monmouth.Middletown, United States

And 41 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • NCT05538130
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (10)

Targets (1)