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

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05538130
Collaborator
(none)
124
6
59.9

Study Details

Study Description

Brief Summary

The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine.

  • In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. Encorafenib comes as a capsule and is taken once per day.

  • In the second part of the study, people with melanoma with a certain type of abnormal gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07284890 or PF-07799933).

Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 ADVANCED SOLID TUMORS
Anticipated Study Start Date :
Nov 8, 2022
Anticipated Primary Completion Date :
May 9, 2026
Anticipated Study Completion Date :
Nov 6, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monotherapy Dose Escalation (Phase 1a)

Participants will receive PF-07799544

Drug: PF-07799544
Tablet
Other Names:
  • ARRY-134
  • Drug: encorafenib
    Capsule
    Other Names:
  • BRAFTOVI
  • Experimental: Phase 1b Substudy A Combination Dose Escalation

    Participants will receive PF-07799544 and PF-07284890

    Drug: PF-07799544
    Tablet
    Other Names:
  • ARRY-134
  • Drug: PF-07284890
    Tablet
    Other Names:
  • ARRY-461
  • Experimental: Phase 1b Substudy A Dose Expansion Cohort 1

    Participants will receive PF-07799544

    Drug: PF-07799544
    Tablet
    Other Names:
  • ARRY-134
  • Experimental: Phase 1b Substudy A Dose Expansion Cohort 2

    Participants will receive PF-07799544 and PF-07284890

    Drug: PF-07799544
    Tablet
    Other Names:
  • ARRY-134
  • Drug: PF-07284890
    Tablet
    Other Names:
  • ARRY-461
  • Experimental: Phase 1b Substudy B Combination Dose Escalation

    Participants will receive PF-07799544 and PF-07799933

    Drug: PF-07799544
    Tablet
    Other Names:
  • ARRY-134
  • Drug: PF-07799933
    Tablet
    Other Names:
  • ARRY-440
  • Experimental: Phase 1b Substudy B Combination Dose Expansion

    Participants will receive PF-07799544 and PF-07799933

    Drug: PF-07799544
    Tablet
    Other Names:
  • ARRY-134
  • Drug: PF-07799933
    Tablet
    Other Names:
  • ARRY-440
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants with dose limiting toxicities (DLTs) Phase 1a monotherapy and Phase 1b combination therapy dose escalation [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. Overall response rate (ORR) (phase 1b expansion) [Baseline to 2 years]

      Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    3. Number of participants with treatment-emergent adverse events (AEs) (phase 1a and 1b dose escalation phases) [Baseline to 28 days after last dose of study medication]

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

    4. Number of participants with clinically significant change from baseline in laboratory abnormalities (phase 1a and phase 1b dose escalation phase) [Baseline to 28 days after last dose of study treatment]

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

    5. Number of participants with clinically significant change from baseline in vital sign abnormalities (phase 1a and phase 1b dose escalation phase) [Baseline to 28 days after last dose of study treatment]

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

    6. Number of participants with clinically significant change from baseline in physical exam abnormalities (phase 1a and phase 1b dose escalation phase) [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.

    Secondary Outcome Measures

    1. ORR (phase 1a and phase 1b dose escalation) [Baseline to 2 years]

      ORR as assessed using the RECIST version 1.1.

    2. Intracranial response (all phases) [Baseline to 2 years]

      Intracranial response by RECIST version 1.1 (for brain metastases)

    3. Duration of response [Baseline to 2 years]

    4. Number of participants with treatment-emergent adverse events (AEs) [Baseline to 2 years]

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

    5. Number of participants with clinically significant change from baseline in laboratory abnormalities [Baseline to 2 years]

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

    6. PK parameters of PF-07799544, Single dose, maximum observed concentration (Cmax) [Baseline to 2 years]

      PK parameters of PF-07799544, Single dose, Cmax

    7. PK parameters of PF-07799544, Single dose, time to maximum plasma concentration (Tmax) [Baseline to 2 years]

      PK parameters of PF-07799544, Single dose, Tmax

    8. PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast) [Baseline to 2 years]

      PK parameters of PF-07799544, Single dose, AUClast

    9. PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) [Baseline to 2 years]

      PK parameters of PF-07799544, Single dose, AUCinf

    10. PK parameters of PF-07799544, Single dose, terminal elimination half life (t½) [Baseline to 2 years]

      PK parameters of PF-07799544, Single dose, t½

    11. PK parameters of PF-07799544, Single dose, apparent oral clearance (CL/F) [Baseline to 2 years]

      PK parameters of PF-07799544, Single dose, CL/F

    12. PK parameters of PF-07799544, Single dose, apparent volume of distribution (Vz/F) [Baseline to 2 years]

      PK parameters of PF-07799544, Single dose, Vz/F

    13. PK parameters of PF-07799544, Multiple dose, maximum observed concentration (Cmax) [Baseline to 2 years]

      PK parameters of PF-07799544, Multiple dose, Cmax

    14. PK parameters of PF-07799544, Multiple dose, time to maximum plasma concentration (Tmax) [Baseline to 2 years]

      PK parameters of PF-07799544, Multiple dose, Tmax

    15. PK parameters of PF-07799544, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCτ) [Baseline to 2 years]

      PK parameters of PF-07799544, Multiple dose, AUCτ

    16. PK parameters of PF-07799544, Multiple dose, terminal elimination half life (t½) [Baseline to 2 years]

      PK parameters of PF-07799544, Multiple dose, t½

    17. PK parameters of PF-07799544, Multiple dose, apparent oral clearance (CL/F) [Baseline to 2 years]

      PK parameters of PF-07799544, Multiple dose, CL/F

    18. PK parameters of PF-07799544, Multiple dose, apparent volume of distribution (Vz/F) [Baseline to 2 years]

      PK parameters of PF-07799544, Multiple dose, Vz/F

    19. PK parameters of PF-07284890, Single dose, maximum observed concentration (Cmax) [Baseline to 2 years]

      PK parameters of PF-07284890, Single dose, Cmax

    20. PK parameters of PF-07284890, Single dose, time to maximum plasma concentration (Tmax) [Baseline to 2 years]

      PK parameters of PF-07284890, Single dose, Tmax

    21. PK parameters of PF-07284890, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast) [Baseline to 2 years]

      PK parameters of PF-07284890, Single dose, AUClast

    22. PK parameters of PF-07284890, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) [Baseline to 2 years]

      PK parameters of PF-07284890, Single dose, AUCinf

    23. PK parameters of PF-07284890, Single dose, terminal elimination half life (t½) [Baseline to 2 years]

      PK parameters of PF-07284890, Single dose, t½

    24. PK parameters of PF-07284890, Single dose, apparent oral clearance (CL/F) [Baseline to 2 years]

      PK parameters of PF-07284890, Single dose, CL/F

    25. PK parameters of PF-07284890, Single dose, apparent volume of distribution (Vz/F) [Baseline to 2 years]

      PK parameters of PF-07284890, Single dose, Vz/F

    26. PK parameters of PF-07284890, Multiple dose, maximum observed concentration (Cmax) [Baseline to 2 years]

      PK parameters of PF-07284890, Multiple dose, Cmax

    27. PK parameters of PF-07284890, Multiple dose, time to maximum plasma concentration (Tmax) [Baseline to 2 years]

      PK parameters of PF-07284890, Multiple dose, Tmax

    28. PK parameters of PF-07284890, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCτ) [Baseline to 2 years]

      PK parameters of PF-07284890, Multiple dose, AUCτ

    29. PK parameters of PF-07284890, Multiple dose, terminal elimination half life (t½) [Baseline to 2 years]

      PK parameters of PF-07284890, Multiple dose, t½

    30. PK parameters of PF-07284890, Multiple dose, apparent oral clearance (CL/F) [Baseline to 2 years]

      PK parameters of PF-07284890, Multiple dose, CL/F

    31. PK parameters of PF-07284890, Multiple dose, apparent volume of distribution (Vz/F) [Baseline to 2 years]

      PK parameters of PF-07284890, Multiple dose, Vz/F

    32. PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax) [Baseline to 2 years]

      PK parameters of PF-07799933, Single dose, Cmax

    33. PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax) [Baseline to 2 years]

      PK parameters of PF-07799933, Single dose, Tmax

    34. PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast) [Baseline to 2 years]

      PK parameters of PF-07799933, Single dose, AUClast

    35. PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) [Baseline to 2 years]

      PK parameters of PF-07799933, Single dose, AUCinf

    36. PK parameters of PF-07799933, Single dose, terminal elimination half life (t½) [Baseline to 2 years]

      PK parameters of PF-07799933, Single dose, t½

    37. PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F) [Baseline to 2 years]

      PK parameters of PF-07799933, Single dose, CL/F

    38. PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F) [Baseline to 2 years]

      PK parameters of PF-07799933, Single dose, Vz/F

    39. PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax) [Baseline to 2 years]

      PK parameters of PF-07799933, Multiple dose, Cmax

    40. PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax) [Baseline to 2 years]

      PK parameters of PF-07799933, Multiple dose, Tmax

    41. PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCτ) [Baseline to 2 years]

      PK parameters of PF-07799933, Multiple dose, AUCτ

    42. PK parameters of PF-07799933, Multiple dose, terminal elimination half life (t½) [Baseline to 2 years]

      PK parameters of PF-07799933, Multiple dose, t½

    43. PK parameters of PF-07799933, Multiple dose, apparent oral clearance (CL/F) [Baseline to 2 years]

      PK parameters of PF-07799933, Multiple dose, CL/F

    44. PK parameters of PF-07799933, Multiple dose, apparent volume of distribution (Vz/F) [Baseline to 2 years]

      PK parameters of PF-07799933, Multiple dose, Vz/F

    45. Number of participants with clinically significant change from baseline in vital sign abnormalities [Baseline to 2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation

    • Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation

    • For Substudy A and B, histological or cytological diagnosis of advanced/metastatic melanoma

    • For Substudy A and B, measurable disease by RECIST version 1.1

    • For Substudy A, evidence of a BRAF V600 mutation in tumor tissue and/or blood

    • For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II alteration in tumor tissue and/or blood

    Exclusion Criteria:
    • Brain metastasis larger than 4 cm

    • Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.

    • 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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05538130
    Other Study ID Numbers:
    • C4901001
    First Posted:
    Sep 13, 2022
    Last Update Posted:
    Sep 13, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pfizer
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 13, 2022