PCA062 in pCAD-positive Tumors.

Novartis

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer; Triple Negative Breast Cancer; Head & Neck Cancer

Treatments: Drug: PCA062

Study type: Interventional

Funder types: Industry

Identifiers

NCT02375958

2014-003732-40 (EudraCT Number)

CPCA062X2101

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
   • 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

Triple Negative Breast Cancer

Experimental group

Treatment:

Drug: PCA062

Head and Neck Cancer

Experimental group

Treatment:

Drug: PCA062

Esophageal Cancer

Experimental group

Treatment:

Drug: PCA062