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Sponsor: Hoffmann-La Roche
Conditions: Neoplasms
Interventions: RO6874813, RO6874813
Countries: United States, France, Spain
This first-in-human study consists of three parts. The primary purpose of Part 1 is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) will be determined. In Part 2 the safety and tolerability of RO6874813 will continue to be characterized in participants with locally advanced and/or metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In addition, treatment-induced efficacy of RO6874813 will be assessed by functional imaging and paired tumor biopsies. The primary purpose of Part 3 is to demonstrate anti-tumor activity of RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Part 1: Participants with histologically/cytologically confirmed locally advanced or metastatic, non-resectable solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists * Part 2: Participants with histologically/ cytologically confirmed locally advanced or metastatic, non-resectable solid tumors known to be FAP+ whose disease has progressed despite standard therapy or for whom no standard therapy exists * Part 3: Participants with histologically confirmed recurrent or metastatic, non-resectable confirmed FAP+ sarcoma with two or fewer prior regimens for advanced disease * All participants must have tumor tissue that can be imaged for pharmacodynamic assessments and from which a pre- and on-treatment biopsy can be safely obtained * An archival tumor sample must be available for retrospective FAP expression analysis * Measurable disease as determined by RECIST v1.1 * World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 * Recovery from all reversible AEs of previous anti-cancer therapies to baseline or Common Terminology Criteria for Adverse Events (CTCAE) Grade 1, except for alopecia (any grade) and Grade \<=2 sensory peripheral neuropathy * Negative pregnancy test Exclusion Criteria: * Primary central nervous (CNS) tumors or CNS tumor involvement * Major surgery or any other prior anti-cancer treatment within 4 weeks prior to study Day 1. * Received wide-field radiotherapy \<= 4 weeks or limited-field radiotherapy \<=2 weeks prior to starting study drug * Known hypersensitivity to any of the components of RO6874813 or to the contrast agents used in the study * Another invasive malignancy in the last 2 years except for those with a minimal risk of metastasis or death * Any other conditions or diseases that would contraindicate participation in the clinical study because of safety concerns or compliance with clinical study procedures
- Nashville, Tennessee, United States
- Lyon, France
- Barcelona, Spain
- Madrid, Spain