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

Pfizer

Status and phase: Active, not recruiting; Phase 1

Conditions: Endometrial Cancer; Bile Duct Cancer; Squamous Cell Carcinoma of the Head and Neck; Melanoma Cancer; Esophageal Cancer; Gastric Cancer; Urothelial Cancer; Lung Squamous Cell Carcinoma; Ovarian Cancer; Renal Cell Carcinoma; Pancreatic Cancer

Treatments: Drug: PF-06940434; Drug: PF-06801591

Study type: Interventional

Funder types: Industry

Identifiers

NCT04152018

2020-004009-29 (EudraCT Number)

C3891001

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

85 participants in 5 patient groups

Dose Escalation

Experimental group

Description:

Single Agent Dose Escalation

Treatment:

Drug: PF-06940434

Dose Finding Anti-PD-1 Combination 1

Experimental group

Description:

Part 1B PF-06940434 plus anti-PD-1

Treatment:

Drug: PF-06801591

Drug: PF-06940434

Dose Expansion Arm A

Experimental group

Description:

PF-06940434 with anti-PD-1 in SCCHN

Treatment:

Drug: PF-06801591

Drug: PF-06940434

Dose Expansion Arm B

Experimental group

Description:

PF-06940434 with anti-PD-1 in RCC

Treatment:

Drug: PF-06801591

Drug: PF-06940434

Dose Expansion, Arm C

Experimental group

Description:

PF-06940434 with anti-PD-1 (both Q3W)

Treatment:

Drug: PF-06801591

Drug: PF-06940434