solide tumoren Cancer solid tumors
Conditions
Interventions
Patients eligible for participation in this study are treated with RO6958688,
see for administration details, page 89-99 of the protocol.
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * For dose escalation, locally advanced and/or metastatic gastrointestinal solid tumor in patients who have progressed on a standard therapy, are intolerant to SOC, and/or are non-amenable to SOC and other solid tumors expressing CEA as per inclusion criterion 14. * Radiologically measurable disease according to RECIST v1.1 * Life expectancy (in the opinion of the investigator) of >
Exclusion criteria
Exclusion criteria: 1.Active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments 2. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for 2 weeks prior to enrollment. 3. Leptomeningeal disease. 4. patients with paraspinal, paratracheal and mediastinal pathological lesions larger than 2 cm inless they are previously irridiated. 5. Patients with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the investigator to be of low likelihood for recurrence) 6. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or contraindicate the use of an investigational drug, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases 7. Patients with bilateral lung lesions and dyspnea and/or with bilateral lung lesions and SaO2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * To assess the safety profile of RO6958688 with/without obinutuzumab pretreatment * To determine the maximum-tolerated dose (MTD) and/or the recommended dose and schedule (optionally with obinutuzumab pretreatment) for further development * To determine the late cycle maximum tolerated dose (late cycle MTD) * To establish the pharmacokinetics of RO6958688 as monotherapy with/without obinutuzumab pretreatment * To assess the effect of obinutuzumab pretreatment in decreasing the rate of patients with positive Anti-Drug Antibodies (ADA) titer against RO6958688 at week 8 and/or delaying the time of onset of ADA against RO6958688 | — |
Secondary
| Measure | Time frame |
|---|---|
| * To obtain preliminary anti-tumor activity data of RO6958688 with/without obinutuzumab pretreatment on objective overall response rate (ORR), duration of response (DOR), Best overall response (BOR), disease control rate (DCR; defined as response rate [RR] stable disease [SD]) and progression-free survival (PFS) on treatment, defined as the time from C1D1 to the first occurrence of objective disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria or immune related response criteria (irRC), by investigator assessment, or death from any cause. If Sponsor decides, independent central read for computed tomography (CT) or magnetic resonance imaging (MRI) might be performed in this study, both prospectively and retrospectively. * To characterize pharmacodynamic (PD) effects and duration of PD response for the once per week (QW), for the every 3 weeks (Q3W) regimens and for the step up dosing scheme QW 3x followed by Q3W on the basis of an increase in activated intratumoral T cells | — |
Countries
Netherlands
Outcome results
None listed