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

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER

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.

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