NCT02375958

Brief Summary

A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2015

Typical duration for phase_1

Geographic Reach
6 countries

7 active sites

Status
completed

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

February 9, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2018

Completed
Last Updated

December 19, 2020

Status Verified

February 1, 2020

Enrollment Period

3.3 years

First QC Date

February 9, 2015

Last Update Submit

December 16, 2020

Conditions

Triple Negative Breast CancerHead & Neck CancerEsophageal Cancer

Keywords

PCA062Triple Negative Breast CancerHead & Neck CancerEsophageal CancerpCAD, pcadherin, solid-tumors

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of dose limiting toxicities

    28 days

Secondary Outcomes (9)

  • Incidence and severity of serious/adverse events

    Duration of study (each treatment cycle = 14 days)

  • Pharmacokinetic parameter Cmax

    84 days

  • Presence of PCA062 anti-bodies

    84 days

  • Overall response rate

    Duration of study (each treatment cycle = 14 days)

  • Duration of response

    Duration of study (each treatment cycle = 14 days)

  • +4 more secondary outcomes

Study Arms (3)

Triple Negative Breast Cancer

EXPERIMENTAL
Drug: PCA062

Head and Neck Cancer

EXPERIMENTAL
Drug: PCA062

Esophageal Cancer

EXPERIMENTAL
Drug: PCA062

Interventions

PCA062DRUG
Esophageal CancerHead and Neck CancerTriple Negative Breast Cancer

Eligibility Criteria

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

You may qualify if:

  • Male or female ≥ 18 years of age
  • Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.
  • Consent for a tumor biopsy at screening
  • Progressive disease and no effective therapy exists
  • Measurable disease as per RECIST v1.1 criteria
  • ECOG Performance status of ≤ 2

You may not qualify if:

  • CNS metastatic involvement
  • Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
  • A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.
  • Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities
  • Previously treated with anti-pCAD biologic therapies.
  • Received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
  • Conventional cytotoxic chemotherapy: ≤4 weeks
  • Biologic therapy (eg, antibodies), other than ADCs: ≤4 weeks
  • Non-cytotoxic small molecule therapeutics: ≤5 T1/2 or ≤2 weeks (whichever is longer)
  • Other investigational agents: ≤4 weeks
  • Radiation therapy (palliative setting is allowed.): ≤4 weeks
  • Major surgery: ≤2 weeks
  • Patient has out of range laboratory values defined as:
  • Hematological values:
  • Absolute neutrophil count (ANC) \<1.5 x 109/L
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Villejuif, 94805, France

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Koto Ku, Tokyo, 135 8550, Japan

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Related Publications (1)

  • Duca M, Lim DW, Subbiah V, Takahashi S, Sarantopoulos J, Varga A, D'Alessio JA, Abrams T, Sheng Q, Tan EY, Rosa MS, Gonzalez-Maffe J, Sand-Dejmek J, Fabre C, Martin M. A First-in-Human, Phase I, Multicenter, Open-Label, Dose-Escalation Study of PCA062: An Antibody-Drug Conjugate Targeting P-Cadherin, in Patients With Solid Tumors. Mol Cancer Ther. 2022 Apr 1;21(4):625-634. doi: 10.1158/1535-7163.MCT-21-0652.

    PMID: 35131875DERIVED

Related Links

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsHead and Neck NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 9, 2015

First Posted

March 3, 2015

Study Start

April 15, 2015

Primary Completion

July 17, 2018

Study Completion

July 17, 2018

Last Updated

December 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)FR(1)JP(1)SG(1)ES(1)IT(1)