A Phase IA/IB, Open Label, Multicenter, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors.
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7502175 as a single agent (Phase Ia) or in combination with the anti-PD-L1 antibody, atezolizumab (Phase Ib), in patients with locally advanced or metastatic solid tumors. Specific objectives and corresponding endpoints for the study.
RO7502175
- Rutgers Cancer Institute of New Jersey
Inclusion Criteria
- Life expectancy at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST)
Version 1.1
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid
tumor malignancy
- Tumor Specimen availability
Exclusion Criteria
- Pregnant or breastfeeding, or intending to become pregnant during the study or within
5 months after the final dose of study treatment
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy,
hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study
treatment
- Active hepatitis B or C or tuberculosis
- Positive test for human immunodeficiency virus (HIV) infection
- Acute or chronic active Epstein-Barr virus (EBV) infection at screening
- Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before
first RO7502175 infusion
- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
- Active or history of autoimmune disease
- Prior allogeneic stem cell or organ transplantation
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.