A Dose Escalation Study of RO6874813 in Participants With Locally Advanced or Metastatic Solid Tumors
Completed · Phase 1
Conditions studied: Neoplasms
In brief
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.
Key facts
- Study ID
- NCT02558140
- Run by
- Hoffmann-La Roche
- People needed
- 120
- Starts
- 2015-10-11
- Expected to finish
- 2017-11-06
- Last updated by the study team
- 2018-04-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- SCRI — Nashville, Tennessee, United States
- Centre Leon Berard; Departement Oncologie Medicale — Lyon, France
- Hospital Univ Vall d'Hebron; Servicio de Oncologia — Barcelona, Spain
- START Madrid. Centro Integral Oncologico Clara Campal; CIOCC — Madrid, Spain
Full record on ClinicalTrials.gov
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