NCT02659631

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2016

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 28, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

January 15, 2016

Results QC Date

March 20, 2020

Last Update Submit

April 27, 2020

Conditions

Neoplasms

Keywords

P-cadherinPF-06671008solid tumorslung cancerbreast cancercolorectal cancerNSCLCTNBCCRCneoplasmsTriple negative breast cancerNon-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Dose-Limiting Toxicities (DLTs) - Part 1

    DLT was defined as any of the following adverse events occurring in the first cycle of treatment (21 days after the first dose): a) Hematologic: Febrile neutropenia defined as an absolute neutrophil count (ANC) \<1.0 x 10\^9/L with a single temperature of \>38.3°C, or 101°F, or a sustained temperature of \>=38°C, or 100.4°F, for more than one hour; b) Non-hematologic: Delay by more than 2 weeks in receiving the next scheduled dose due to persisting treatment related toxicities; c) Any grade 3 or 4 clinically-relevant hematologic or non-hematologic toxicity.

    Baseline through Day 21 (Cycle 1)

  • Number of Participants With Objective Response (OR) - Part 2

    Number of participants with OR based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

    Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months

Secondary Outcomes (11)

  • Maximum Serum Concentration (Cmax) of PF-06671008

    C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose

  • Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06671008

    C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose

  • Terminal Elimination Half-life (t1/2) of PF-06671008

    C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose

  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06671008

    C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose

  • Area Under the Curve From Time 0 Extrapolated to Infinity Time (AUCinf) of PF-06671008

    C1D1 0, 1, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose, C2D1 0, 2, 4, 8, 24, 48, 72 and 96 hrs post-dose

  • +6 more secondary outcomes

Study Arms (1)

PF-06671008

EXPERIMENTAL
Drug: PF-06671008

Interventions

PF-06671008DRUG

Dose Escalation Phase - Part 1

PF-06671008

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Memorial Sloan Kettering Cancer Center - Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center- Clinical Trials Office

New York, New York, 10017, United States

Location

Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion

New York, New York, 10022, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

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

Houston, Texas, 77030, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Hospital

Salt Lake City, Utah, 84112, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • 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.

    PMID: 35493516DERIVED

Related Links

MeSH Terms

Conditions

NeoplasmsLung NeoplasmsBreast NeoplasmsColorectal NeoplasmsTriple Negative Breast NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

PF-06671008

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

April 28, 2016

Primary Completion

March 29, 2019

Study Completion

March 29, 2019

Last Updated

May 6, 2020

Results First Posted

May 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

US(9)