Brief Title
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
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
Brief 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 2
cohorts at doses determined from Part 1B in order to further evaluate the safety of
PF-06940434 in combination with anti-PD-1.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding
Secondary Outcome
PF-06940434 after multiple doses PK parameters (Cmax).
Condition
Squamous Cell Carcinoma of the Head and Neck
Intervention
PF-06940434
Study Arms / Comparison Groups
Dose Escalation
Description: Single Agent Dose Escalation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
104
Start Date
November 13, 2019
Completion Date
February 12, 2025
Primary Completion Date
February 12, 2025
Eligibility Criteria
Inclusion Criteria:
- 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.
Part 2:
- Arm A SCCHN:
- Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
- PDL-1 expression positive and CPS ≥1. No prior systemic therapy administered in
the recurrent or metastatic setting (except for systemic therapy given as part of
a multimodal treatment for locally advanced disease).
- Arm B RCC (clear cell):
- 1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination
or sequentially with antiangiogenic directed treatment
- Adequate bone marrow, kidney and liver function.
- Performance status of 0 or 1.
Exclusion Criteria:
- Participant disease status is suitable for local therapy administered with curative
intent.
- Hypertension that cannot be controlled by medications.
- Active or prior autoimmune disease
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited
to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or
Acquired Immunodeficiency Syndrome-related illness
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, 1-800-718-1021, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT04152018
Organization ID
C3891001
Secondary IDs
2020-004009-29
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
March 2023