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Monoclonal Antibodies
RO7515629 for Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unresectable and/or metastatic HLA-G-positive solid tumors, for which standard therapy does not exist, or has proven to be ineffective or intolerable
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 18 months
Awards & highlights
Study Summary
This trial evaluates a drug to treat advanced or metastatic tumors that express HLA-G, looking at safety, effectiveness, how the body responds, and how it's absorbed.
Who is the study for?
This trial is for adults with certain advanced solid tumors expressing HLA-G, who have tried standard treatments without success or can't tolerate them. They must be in relatively good health (ECOG 0 or 1), not have other recent cancers, serious heart conditions, active infections including HIV and hepatitis B/C, uncontrolled high blood pressure, lung complications like ILD/pneumonitis, or CNS metastases.Check my eligibility
What is being tested?
The study tests RO7515629 alone to see how safe it is and how well people with HLA-G positive tumors respond to it. It also looks at the drug's effects on the body (pharmacokinetics) and immune system response. Tocilizumab may be used if needed for managing side effects.See study design
What are the potential side effects?
Possible side effects of RO7515629 include reactions related to infusion of the drug into the bloodstream, changes in immune function that could lead to inflammation in various organs, fatigue, and potential worsening of pre-existing lung conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be removed by surgery, has spread, and does not respond to standard treatments.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Part 1, 2, 3: Disease Control Rate (DCR)
Part 1, 2, 3: Duration of Response (DoR)
Part 1, 2, 3: Number of Participants With RO7515629 Anti-drug Antibodies (ADAs)
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part III Multiple Participant Cohort RO7515629 Dose ExpansionExperimental Treatment2 Interventions
Participants with selected solid tumors will receive a selected dose of RO7515629 intravenously as a single agent based on the recommended dose sequence for expansion (RDE) and dosing regimen selected from Part I and Part II. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
Group II: Part II Multiple Participant Cohort RO7515629 Dose EscalationExperimental Treatment2 Interventions
Participants will receive RO7515629 intravenously, as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. In case of toxicity, step up dosing (single or double) may be implemented. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
Group III: Part I Single Participant Cohort RO7515629 Dose EscalationExperimental Treatment2 Interventions
Participants will receive a fixed dose of RO7515629 intravenously as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tocilizumab
2014
Completed Phase 4
~940
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,904 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,352 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have active hepatitis B or C based on specific test results.I have not had major surgery in the last 4 weeks.I last received immune therapy less than 28 days ago.I have a serious heart condition.I haven't had a serious infection or needed IV antibiotics in the last 4 weeks.My cancer cannot be removed by surgery, has spread, and does not respond to standard treatments.I have an autoimmune disease but haven't needed systemic therapy in the last 2 years.I haven't taken any cancer treatment or trial drugs in the last 28 days.You have a tube or line inside your body.I haven't taken more than 10 mg/day of prednisone or its equivalent in the last 28 days.My high blood pressure is not under control.I am HIV positive.Your tumor is touching or growing into major blood vessels, or your doctor thinks it might cause dangerous bleeding.I have or had brain metastases but meet specific criteria.My lung cancer has spread in a specific pattern.I am fully active or restricted in physically strenuous activity but can do light work.My blood, liver, kidney, and lung functions are all within normal ranges.Your disease can be seen and measured on a radiology scan using specific guidelines.I haven't had another type of cancer in the last 2 years.I am not allergic to RO7515629, tocilizumab, or dexamethasone.You are expected to live for at least 12 more weeks.I have not received a live vaccine within the last 28 days.My cancer has spread to the lining of my brain and spinal cord.My cancer is growing quickly and threatens important organs.I have not had a pulmonary embolism in the last 3 months.I have or had lung conditions needing steroid treatment.I have previously undergone T cell therapy.My tumor shows HLA-G expression, or I can have a biopsy if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Part I Single Participant Cohort RO7515629 Dose Escalation
- Group 2: Part III Multiple Participant Cohort RO7515629 Dose Expansion
- Group 3: Part II Multiple Participant Cohort RO7515629 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the community involved in this clinical research?
"Affirmative. The clinicaltrials.gov page for this experiment states that recruitment is ongoing, with the study being first published on May 31st 2023 and amended lastly on May 4th 2023. Enrollment requires 150 people to be sourced from 2 centers."
Answered by AI
Is enrollment still open for this research endeavor?
"Affirmative. Clinicaltrials.gov exhibits that this medical trial, initially posted on May 31st 2023, is still actively seeking participants. Approximately 150 people need to be recruited from 2 distinct healthcare facilities."
Answered by AI
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