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Tests treatment safety and results for Locally Advanced Solid Tumors
Official title A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06031441
What this study is testing
What is RO7566802?
RO7566802 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Measurable disease per RECIST v1.1
You likely can't join if
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to...
- 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
See the full eligibility 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...
- Measurable disease per RECIST v1.1
- Tumor specimen availability, for certain cohorts
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- New Haven, Connecticut, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Harrisburg, Pennsylvania, United States
- Nashville, Tennessee, United States
- Darlinghurst, New South Wales, Australia
- Melbourne, Victoria, Australia
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Singapore, Singapore
- Cambridge, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Oxford, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; New Haven, Connecticut, United States; New York, New York, United States; Columbus, Ohio, United States; Harrisburg, Pennsylvania, United States; Nashville, Tennessee, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.