Evaluating RO7566802 and Atezolizumab for advanced solid tumors
A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
This study is testing a new treatment called RO7566802, both alone and with another drug called atezolizumab, to see if it can help people with advanced solid tumors that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, atezolizumab |
| Locations | 18 sites (Birmingham, Alabama and 17 other locations) |
| Trial ID | NCT06031441 on ClinicalTrials.gov |
What this trial studies
This Phase I clinical trial aims to assess the safety, pharmacokinetics, and preliminary anti-tumor activity of RO7566802, both as a standalone treatment and in combination with atezolizumab, in patients with locally advanced, recurrent, or metastatic solid tumors. The study will be conducted in two stages: a dose escalation phase to determine the optimal dosing and an expansion phase to further evaluate the treatment's effects. Participants must have tumors that have progressed after standard therapies or for whom such therapies are not suitable.
Who should consider this trial
Good fit: Ideal candidates include individuals with locally advanced or metastatic solid tumors that have not responded to standard treatments.
Not a fit: Patients currently receiving other anti-cancer therapies or those with active infections like hepatitis or HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Life expectancy \>=3 months, in the investigator's judgment * Adequate hematologic and end-organ function * Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care * Measurable disease per RECIST v1.1 * Tumor specimen availability, for certain cohorts Exclusion Criteria: * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to Cycle 1 Day 1, with certain exceptions * Active hepatitis B or C * Active tuberculosis * Positive test for human immunodeficiency virus (HIV) infection * Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Active or history of autoimmune disease * Prior allogeneic stem cell or organ transplantation * Uncontrolled tumor-related pain * Significant cardiovascular disease Other protocol-defined inclusion/exclusion criteria may apply.
Where this trial is running
Birmingham, Alabama and 17 other locations
- University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States (Recruiting)
- Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai (ISMMS) — New York, New York, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- Magee-Woman's Hospital — Harrisburg, Pennsylvania, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (Recruiting)
- Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- British Columbia Cancer Agency - 600 10th Ave W — Vancouver, British Columbia, Canada (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- National University Hospital — Singapore, Singapore (Recruiting)
- National Cancer Centre — Singapore, Singapore (Recruiting)
- Addenbrooke's Hospital — Cambridge, United Kingdom (Recruiting)
- Leicester Royal Infirmary — Leicester, United Kingdom (Recruiting)
- St Bartholomew's Hospital — London, United Kingdom (Recruiting)
- Sarah Cannon Research Institute — London, United Kingdom (Recruiting)
- Churchill Hospital — Oxford, United Kingdom (Recruiting)
- The Royal Marsden hospital — Sutton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: GO44431 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.