| General information |
| Database: | DB00680 |
| Objective: | Patritumab (U31287) is a human epidermal growth factor receptor3 (HER3)targeted antibody that blocks ligandassociated activation of HER3. This openlabel, phase 1 and dosefinding study (ClinicalTrials.jp Identifier: JapicCTI101262) aimed to assess the safety, pharmacokinetics, incidence of antipatritumab antibody, recommended dose for subsequent clinical studies, preliminary efficacy, and patritumabrelated biomarkers in Japanese patients with advanced solid tumors. |
| Authors: | Wakui H, et al |
| Title: | Phase 1 and dosefinding study of patritumab (U31287), a human monoclonal antibody targeting HER3, in Japanese patients with advanced solid tumors. |
| Journal: | Cancer Chemother Pharmacol |
| Year: | 2014 |
| PMID: | 24442032 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | patritumab
|
| Target: | Receptor proteintyrosine kinase erbB3
|
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced solid tumors |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, phase I and dosefinding study |
| Key Patients Feature: | Eligible patients had histologically or cytologically confirmed advanced solid tumors that were refractory tostandard treatment and were well known to express HER3(e.g., lung, breast, colorectal, cervical, esophageal and sarcoma). Eligibility criteria also included the following: age20-75 years at informed consent; Eastern CooperativeOncology Group (ECOG) performance status (PS) 0-1;life expectancy greater than 3 months; no previous chemotherapy, radiation therapy, hormonal therapy or surgerywithin 4 weeks before treatment with patritumab (6 weeksfor previous treatment with nitrosoureas or mitomycinC); and adequate hematologic, hepatic and renal function.Any toxicity related to prior therapy must have recovered. |
| Biomarker: | Soluble HER3 concentration in serum |
| Biomark Analysis: | Soluble HER3 concentration in serum unexpectedly increased in all patients. These changes did not correlate with clinical response |
| Control Group Info: | single arm, |
| Treatment Info: | Patients received patritumab 9 or 18 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity occurred. |
| Primary End Point: | DLTs, MDT, Aes and tumor response |
| Secondary End Point: | NA |
| Patients Number: | 9 |
| Trial Results |
| DLT_MTD: | No DLTs were reported. |
| Objective Response Rate: | These changes did not correlate with clinical response. Four patients had a best response of stable disease. All patients tested had negative for antipatritumab antibody formation. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Patritumabrelated AEs reported in more than and equal to 2 patients were ALT increase (three patients), thrombocytopenia, diarrhea, stomatitis, cheilitis, rash maculopapular and AST increase (two each). |
| Conclusions: | Patritumab was well tolerated up to 18 mg/kg without DLTs in Japanese patients with advanced solid tumors. Soluble HER3 increased in all patients. |