Gevorderde solide tumoren advanced solid tumors
Conditions
Interventions
None listed
Sponsors
Chugai Pharma Europe Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: * Histologically confirmed and measurable malignant solid tumor and/or metastatic disease not amenable to standard therapy or for which standard therapy is not available or not indicated * GPC3 positive tumor by immunohistochemistry (IHC) on a biopsy sample *18 months old at the time of IHC analysis * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Adequate hematological, hepatic, renal, coagulation and nutritional status * For female patients of child-bearing potential a negative serum pregnancy test * Life expectancy *3 months. Inclusion Criteria Unique to Cohort Expansion: * Cohort A: GPC3 positive and histologically confirmed gastric or GEJ adenocarcinoma * Cohort B: GPC3 positive and histologically confirmed head and neck squamous cell carcinoma * Cohort C: GPC3 positive and histologically confirmed sarcoma * Cohort D: Any other GPC3 positive solid tumor that is advanced and/or metastatic and either not amenable to standard therapy or for which standard therapy is not available or not indicated o The cut-off value for GPC3 expression in each of the cohort expansion groups may be determined based on data generated in the dose escalation part of the study. These cut-off values will be communicated, in writing, to each site prior to initiation of cohort expansion.
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: * Patients with more than a single brain metastasis, a single brain metastasis > 1 cm in size, or a single brain metastasis *1 cm size but not stable for 4 weeks or longer * Current or previous interstitial lung disease evident on imaging * Requirement of regular drainage of ascites and/or pleural effusion * Treatment with monoclonal antibodies (except for denosumab) or other immunotherapy within 28 days prior to first receipt of study drug * Prior treatment with other excluded therapies * Patients with clinically significant (as determined by the investigator) acute or chronic infection or infection occurring during the 14 days prior to first receipt of study drug * Patients with known human immunodeficiency virus * Hepatitis B virus (HBV) surface antigen, HBV core antibody and hepatitis C (HCV) core antibody will be tested at screening. Patients with active (HBV, and/or active HCV infection or any other known active virus infection considered to be clinically relevant by the investigator. * Major surgery within 28 days prior to first receipt of study drug * Patients with allergic reactions attributed to components of the formulated study drug, corticosteroids or anti-histamines * Patients with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the investigator to have a low likelihood for recurrence). Exclusion Criteria Unique to Dose Escalation * Subjects with histologically confirmed lung cancer and hepatocellular carcinoma (HCC) will be excluded from the fixed dose cohorts. These subjects can be enrolled into the individual dose titration cohort.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Analysis Safety will be determined by summaries of AEs, SAEs, laboratory test results, vital signs, and death. All patients who receive any dose of ERY974 and have at least one assessment for safety will be included into the safety analysis. DLTs will be described by cohorts and treatment. Tumor response will be described by treatment group. Determination of Sample Size For dose escalation, the sample size is based on the dose-escalation rules described in the study design section. The planned enrollment for the dose escalation phase is approximately 50 patients. Approximately 25 patients may be recruited in each of Cohorts A, B and C. | — |
Countries
Netherlands
Outcome results
None listed