Evaluating RO7567132 alone and with Atezolizumab in advanced solid tumors
An Open-label, Multicenter, Dose-escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
This study is testing a new treatment called RO7567132, alone and with another drug called atezolizumab, to see if it can help adults with advanced solid tumors who haven't had success with other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | atezolizumab |
| Locations | 11 sites (Darlinghurst, New South Wales and 10 other locations) |
| Trial ID | NCT06537310 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RO7567132, both as a standalone treatment and in combination with atezolizumab, in adults with advanced solid tumors. Participants will be those for whom standard therapies are ineffective or intolerable. The study will involve dose-escalation to determine the optimal dosing regimen. Archival tumor specimens or fresh biopsies will be required for evaluation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors and an ECOG performance status of 0 to 1.
Not a fit: Patients with known central nervous system tumors, active second malignancies, or significant cardiovascular or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited or no effective therapies available.
How similar studies have performed: Other studies have shown promise in using combination therapies for advanced solid tumors, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female participants aged ≥18 years * Body weight \> 40 kilograms (kg) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks * Participants with advanced and/or metastatic solid tumors * Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy * Negative serum pregnancy test * Participants must have adequate cardiovascular, hematological, liver and renal function. Exclusion Criteria: * Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases * Active second malignancy within 2 years prior to screening * History or current clinically significant cardiovascular/cerebrovascular disease * Active or history of autoimmune disease * Serious, uncontrolled infection * Known clinically significant liver disease * Unresolved acute toxicity \> grade 1 from prior therapy
Where this trial is running
Darlinghurst, New South Wales and 10 other locations
- Kinghorn Cancer Centre — Darlinghurst, New South Wales, Australia (Recruiting)
- Austin Health — Heidelberg, Victoria, Australia (Recruiting)
- UZ Leuven Gasthuisberg — Leuven, Belgium (Recruiting)
- BC Cancer ? Vancouver — Vancouver, British Columbia, Canada (Recruiting)
- Princess Margaret Cancer Center — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Center — Montreal, Quebec, Canada (Recruiting)
- Rigshospitalet — København Ø, Denmark (Recruiting)
- Clinica Universidad de Navarra — Pamplona, Navarra, Spain (Recruiting)
- Vall d?Hebron Institute of Oncology (VHIO), Barcelona — Barcelona, Spain (Recruiting)
- Clinica Universidad de Navarra Madrid — Madrid, Spain (Recruiting)
- Fundacion Jimenez Diaz — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: BP44956 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.