Clinical Trials List
Protocol NumberCPCA062X2101
NCT Number(ClinicalTrials.gov Identfier)NCT02375958
2016-05-01 - 2018-10-05
Phase I
Terminated1
ICD-9199.1
Malignant neoplasm of unspecified site (primary) (secondary)
A phase I, multicenter, open-label dose escalation and expansion study of PCA062, administered intravenously in adult patients with pCAD-positive tumors
-
Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
Novartis Pharmaceuticals
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- YEN-SHEN LU Division of Hematology & Oncology
- Chih-Hung Hsu Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
- HUAI-CHENG HUANG Division of Hematology & Oncology
- 林季宏 Division of Hematology & Oncology
- TA-CHEN HUANG Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
advanced malignancy
Objectives
The purpose of this study is to determine the maximum tolerated
dose (MTD) or recommended dose for expansion (RDE) of
PCA062 in patients with pCAD-positive tumors and to estimate
the preliminary anti-tumor activity of PCA062 in this
population.
Test Drug
PCA062
Active Ingredient
PCA062
Dosage Form
lyophilized powder for solution
Dosage
50 mg/vial
Endpoints
Efficacy assessments
Tumor assessment per RECIST v1.1
Safety assessments
Incidence and severity of adverse events (AEs) and serious
adverse events (SAEs), including changes in laboratory values,
vital signs and electrocardiograms (ECGs) and immunogenicity
Other assessments
Pharmacokinetics will be assessed using serum PK parameters
(eg, AUC, Cmax, Tmax, half-life) and serum concentration vs.
time profiles for total Ab , total ADC, and unconjugated drug
(free DM1).
Tumor assessment per RECIST v1.1
Safety assessments
Incidence and severity of adverse events (AEs) and serious
adverse events (SAEs), including changes in laboratory values,
vital signs and electrocardiograms (ECGs) and immunogenicity
Other assessments
Pharmacokinetics will be assessed using serum PK parameters
(eg, AUC, Cmax, Tmax, half-life) and serum concentration vs.
time profiles for total Ab , total ADC, and unconjugated drug
(free DM1).
Inclution Criteria
Select Inclusion criteria
Patients must meet the following criteria:
Male or female ≥ 20 years of age
Documented pCAD expressing tumor cells. An archived
tumor sample taken after the completion of the last prior
treatment regimen 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
Patients must meet the following criteria:
Male or female ≥ 20 years of age
Documented pCAD expressing tumor cells. An archived
tumor sample taken after the completion of the last prior
treatment regimen 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
Exclusion Criteria
Select Exclusion criteria
Patient has any of the following:
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
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
Patient has any of the following:
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
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
The Estimated Number of Participants
-
Taiwan
8 participants
-
Global
90 participants
