Clinical Trials Directory

Trials / Terminated

TerminatedNCT04152018

Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

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

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
85 (actual)
Sponsor
Pfizer · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) 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) and dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.

Conditions

Interventions

TypeNameDescription
DRUGPF-06940434PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
DRUGPF-06801591PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.

Timeline

Start date
2019-11-13
Primary completion
2024-12-10
Completion
2024-12-10
First posted
2019-11-05
Last updated
2025-05-28

Locations

31 sites across 5 countries: United States, Australia, Slovakia, South Korea, Taiwan

Regulatory

Source: ClinicalTrials.gov record NCT04152018. Inclusion in this directory is not an endorsement.