PF-06671008 Dose Escalation Study in Advanced Solid Tumors

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Neoplasms

Treatments: Drug: PF-06671008

Study type: Interventional

Funder types: Industry

Identifiers

NCT02659631

B7831001

Details and patient eligibility

About

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin expression. The study will then expand to look at the selected dose in patients with P-cadherin expressing TNBC, CRC or NSCLC.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Diagnosis of tumor type with the potential to have P-cadherin expression that is resistant to standard therapy or for which no standard therapy is available
• Performance status of 0 or 1
• Adequate bone marrow, kidney and liver function

Key Exclusion Criteria

• Known CNS disease including, but not limited to, metastases
• Current or history of seizure disorder
• History of or active autoimmune disorders
• Active bacterial, fungal or viral infection
• Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study treatment
• Requirement for systemic immune suppressive medication
• Grade 2 or greater peripheral neuropathy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

PF-06671008

Experimental group

Treatment:

Drug: PF-06671008

Drug: PF-06671008