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Monoclonal Antibodies
RO7502175 + Atezolizumab for Advanced Cancers
Phase 1
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Study Summary
This trial tests a new drug to see if it's safe and effective in treating multiple cancers.
Who is the study for?
This trial is for adults with certain advanced solid tumors who have a good performance status, measurable disease, and a life expectancy of at least 12 weeks. They must not be pregnant or breastfeeding, have untreated brain metastases, recent cancer treatments, active hepatitis B/C or tuberculosis, HIV infection, autoimmune diseases or live vaccine administration within the last month.Check my eligibility
What is being tested?
The study tests RO7502175 alone and combined with Atezolizumab in patients with various solid tumors. It's conducted in two parts: first to find the right dose (dose escalation) and then to see how well it works at that dose (dose expansion).See study design
What are the potential side effects?
Possible side effects include reactions related to infusion of the drugs, potential immune system-related issues due to Atezolizumab's action on the body's defenses against cancer cells as well as general drug side effects like fatigue and digestive disturbances.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)
Phase Ia: Number of Participants with Treatment Emergent Adverse Events
Phase Ib: Number of Participants with DLTs
+1 moreSecondary outcome measures
Phase Ia and Phase Ib: Duration of Response (DOR)
Serum
Phase Ia and Phase Ib: Objective Response Rate (ORR)
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Phase Ib: ExpansionExperimental Treatment2 Interventions
Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ib Dose Escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Group II: Phase Ib: Dose EscalationExperimental Treatment2 Interventions
Participants in successive cohorts will receive escalating doses of RO7502175, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Group III: Phase Ia: ExpansionExperimental Treatment1 Intervention
Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Group IV: Phase Ia: Dose EscalationExperimental Treatment1 Intervention
Participants in successive cohorts will receive escalating doses of RO7502175, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
567,748 Total Patients Enrolled
11 Trials studying Hepatocellular Carcinoma
537 Patients Enrolled for Hepatocellular Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a live vaccine in the last 4 weeks.I can provide a sample of my tumor for testing.I have brain metastases that are untreated or getting worse.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is advanced, has come back, or spread and cannot be cured.I haven't had any cancer treatment, including chemotherapy or radiotherapy, in the last 3 weeks.I have active hepatitis B, C, or tuberculosis.You are expected to live for at least 12 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Phase Ia: Expansion
- Group 2: Phase Ia: Dose Escalation
- Group 3: Phase Ib: Expansion
- Group 4: Phase Ib: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Hepatocellular Carcinoma Patient Testimony for trial: Trial Name: NCT05581004 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA endorsed Phase Ib: Dose Escalation protocol?
"Our internal assessment has determined that Phase Ib: Dose Escalation carries a low risk rating of 1, as this is still an exploratory stage of testing and there are limited studies available to support safety or efficacy."
Answered by AI
Are there any available positions in this research study yet?
"According to the information on clinicaltrials.gov, this project is still seeking participants. It was initially posted October 31st 2022 and last updated November 4th 2022."
Answered by AI
How many individuals are being recruited for participation in this clinical trial?
"In order to meet the requirements of this medical study, 365 patients that comply with the given criteria are sought after. Potential participants can join from different sites including Winship Cancer Institute in Atlanta and Florida Cancer Specialists - Sarasota in Sarasota."
Answered by AI
Who else is applying?
What site did they apply to?
Princess Margaret Cancer Centre
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
As mentioned, I tried treatment with a protocol that managed the tumor markers (I had an ER positive, HER negative tumor), then took Lynparza for a month but stopped due to side effects.
PatientReceived 1 prior treatment
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