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PCA062 in pCAD-positive Tumors. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

PCA062 in pCAD-positive Tumors.

A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors

NCT02375958•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female ≥ 18 years of age
•2. 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.
•3. Consent for a tumor biopsy at screening
•4. Progressive disease and no effective therapy exists
•5. Measurable disease as per RECIST v1.1 criteria
•6. ECOG Performance status of ≤ 2

Exclusion Criteria

•1. CNS metastatic involvement
•2. Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
•3. A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.
•4. 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
•5. Previously treated with anti-pCAD biologic therapies.
•6. 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
+11 more criteria

Locations (7)

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

San Antonio, Texas, United States

Novartis Investigative Site

Villejuif, France

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Koto Ku, Tokyo, Japan

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Madrid, Spain

Key Dates

Start Date

April 15, 2015

Primary Completion Date

July 17, 2018

Completion Date

July 17, 2018

Last Updated

December 19, 2020

Enrollment

ACTUAL participants

Conditions

Triple Negative Breast CancerHead & Neck CancerEsophageal Cancer

Interventions

PCA062

DRUG

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Gastric CancerColon Cancer+4 more

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PCA062 in pCAD-positive Tumors.

Inclusion Criteria

Exclusion Criteria

Resilience and Equity in Aging, Cancer, and Health (REACH)

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