PF-06671008 Dose Escalation Study in Advanced Solid Tumors

NCT ID: NCT02659631

Last Updated: 2020-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-28

Study Completion Date

2019-03-29

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-06671008

Group Type EXPERIMENTAL

PF-06671008

Intervention Type DRUG

Dose Escalation Phase - Part 1

PF-06671008

Intervention Type DRUG

Dose Expansion Phase - Part 2

Interventions

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PF-06671008

Dose Escalation Phase - Part 1

Intervention Type DRUG

PF-06671008

Dose Expansion Phase - Part 2

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Memorial Sloan Kettering Cancer Center - Westchester

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center- Clinical Trials Office

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

The University of Texas - M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Huntsman Cancer Hospital

Salt Lake City, Utah, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Harding JJ, Garrido-Laguna I, Chen X, Basu C, Dowlati A, Forgie A, Hooper AT, Kamperschroer C, Max SI, Moreau A, Shannon M, Wong GY, Hong DS. A Phase 1 Dose-Escalation Study of PF-06671008, a Bispecific T-Cell-Engaging Therapy Targeting P-Cadherin in Patients With Advanced Solid Tumors. Front Immunol. 2022 Apr 14;13:845417. doi: 10.3389/fimmu.2022.845417. eCollection 2022.

Reference Type DERIVED
PMID: 35493516 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7831001

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Other Identifiers

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B7831001

Identifier Type: -

Identifier Source: org_study_id

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