Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
47 participants
INTERVENTIONAL
2015-04-15
2018-07-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Triple Negative Breast Cancer
PCA062
Head and Neck Cancer
PCA062
Esophageal Cancer
PCA062
Interventions
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PCA062
Eligibility Criteria
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Inclusion Criteria
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
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
* Radiation therapy (palliative setting is allowed.): ≤4 weeks
* Major surgery: ≤2 weeks
7. Patient has out of range laboratory values defined as:
* Hematological values:
* Absolute neutrophil count (ANC) \<1.5 x 109/L
* Hemoglobin (Hgb) \<9 g/dL
* Platelets \<100 x 109/L
* Hepatic and renal function
* Total bilirubin \>1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin \>2.5 x ULN.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 x ULN for patients without tumor involvement of the liver or \>5 x ULN for patients with tumor involvement of the liver.
* Serum creatinine \>1.5 x ULN and/or measured creatinine clearance \< 40 ml/min
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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References
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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.
Related Links
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Results for CPCA062X2101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2014-003732-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CPCA062X2101
Identifier Type: -
Identifier Source: org_study_id