Clinical trial · Interventional
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
NCT02375958CI-TRIAL-00048991completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Head & Neck Cancer | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PCA062 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Triple Negative Breast Cancer
- interventionNames
- Drug: PCA062
- type
- EXPERIMENTAL
- label
- Head and Neck Cancer
- interventionNames
- Drug: PCA062
- type
- EXPERIMENTAL
- label
- Esophageal Cancer
- interventionNames
- Drug: PCA062
Primary outcomes (1)
- measure
- Incidence rate of dose limiting toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDuca 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 35131875