A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors

Purpose

This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.

Conditions

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC, urothelial carcinoma or HNSCC - Progressed after at least 1 line of treatment and no more than 3 lines of treatment - At least one measurable lesion as defined by RECIST version 1.1 - ECOG Performance Status 0 or 1 - Adequate Bone Marrow Function - Adequate Renal Function - Adequate Liver Function - Resolved acute effects of any prior therapy

Exclusion Criteria

  • Known active uncontrolled or symptomatic CNS metastases. - Major surgery, radiation therapy, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. - Active, uncontrolled infection, including COVID-19 - Known or suspected hypersensitivity to PF-06939999 - Inability to consume or absorb study drug

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Dose Escalation and Dose expansion
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation 		Participants will receive PF-06939999 orally at escalating doses in 28 day cycles on a continuous basis
  • Drug: PF-06939999 dose escalation
    PF-06939999 orally at escalating doses on a continuous basis
    Other names:
    • PRMT5 inhibitor
Experimental
Non small cell lung cancer monotherapy 		Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
  • Drug: PF-06939999 monotherapy
    PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
    Other names:
    • PRMT5 inhibitor
Experimental
Urothelial carcinoma 		Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
  • Drug: PF-06939999 monotherapy
    PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
    Other names:
    • PRMT5 inhibitor
Experimental
Head and neck squamous cell carcinoma 		Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
  • Drug: PF-06939999 monotherapy
    PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
    Other names:
    • PRMT5 inhibitor
Experimental
Non small cell lung cancer PF-06939999 plus docetaxel 		Participants will receive PF-06939999 on a continuous basis in combination with docetaxel
  • Drug: PF-06939999 in combination with docetaxel
    PF-06939999 orally on a continuous basis in combination with docetaxel
    Other names:
    • PRMT5 inhibitor
Experimental
Non small cell lung cancer dose finding 		Participants will receive PF-06939999 on a continuous basis at escalating doses in combination with docetaxel
  • Drug: PF-06939999 in combination with docetaxel
    PF-06939999 orally on a continuous basis in combination with docetaxel
    Other names:
    • PRMT5 inhibitor

More Details

Status
Terminated
Sponsor
Pfizer

Study Contact

For general questions about clinical trials, contact Research Support Services at (615) 322-7343 or research.support.services@vumc.org