Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B), biopsy cohorts with monotherapy lead-in at the maximum tolerated dose (MTD) or maximum administered dose (MAD), followed by combination of anti-PD-1 [PF-06801591] (Part 1C) followed by dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 2 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.

Official Title

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS

Keywords

Squamous Cell Carcinoma of the Head and Neck Renal Cell Carcinoma Ovarian Cancer Gastric Cancer Esophageal Cancer Lung Squamous Cell Carcinoma Pancreatic Cancer Bile Duct Cancer Endometrial Cancer Melanoma Cancer Urothelial Cancer Carcinoma Carcinoma, Squamous Cell Endometrial Neoplasms Squamous Cell Carcinoma of Head and Neck Bile Duct Neoplasms Dose Escalation

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell), ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma, or urothelial cancer.
  • Adequate bone marrow, kidney and liver function.
  • Performance status of 0 or 1.

You CAN'T join if...

  • Participant disease status is suitable for local therapy administered with curative intent.
  • Hypertension that cannot be controlled by medications.

Locations

  • Ronald Reagan UCLA Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Hematology Oncology not yet accepting patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology not yet accepting patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04152018
Phase
Phase 1
Study Type
Interventional
Last Updated