A Dose Escalation Study of RO6874813 in Participants With Locally Advanced or Metastatic Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | October 11, 2015 |
| End Date: | November 6, 2017 |
An Open-Label, Multicenter, Dose-Escalation Phase I Study of RO6874813, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
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.
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.
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
We found this trial at
2
sites
28 Promenade Léa et Napoléon Bullukian
Lyon, 69373
Lyon, 69373
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