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Monoclonal Antibodies
RO7122290 + Cibisatamab for Colorectal 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 28 months
Awards & highlights
Study Summary
This trial is testing a new drug combination to treat colorectal cancer that has progressed despite prior treatment. The goal is to find the best dose of the new drugs to give with the least side effects.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that's microsatellite-stable or MSI-low and has high CEACAM5 expression. Participants must have progressed after standard treatments, be in good physical condition (ECOG 0 or 1), have normal kidney function, adequate organ functions, a life expectancy of at least 12 weeks, and use effective contraception.Check my eligibility
What is being tested?
The study tests the combination of RO7122290 and Cibisatamab following Obinutuzumab pretreatment to find the safest dose with potential anti-tumor effects. It's an early-phase trial involving participants who receive these drugs on weekly or every three-week schedules to assess tolerability and preliminary effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drug administration process, fatigue, possible changes in blood counts leading to increased infection risk or bleeding tendencies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 28 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 28 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part I: Occurrence of dose-limiting toxicities
Percentage of Participants with Adverse Events
Secondary outcome measures
Area under the curve (AUC) of Cibisatamab
Area under the curve (AUC) of Obinutuzumab
Area under the curve (AUC) of RO7122290
+41 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part II: Dose-expansion of RO7122290Experimental Treatment3 Interventions
Part II of this study will evaluate selected dose levels of RO7122290 from Part I (a QW RO712290 administration in combination with a Q3W cibisatamab administration with obinutuzumab pre-treatment) in a Q3W regimen in combination with a Q3W cibisatamab administration with obinutuzumab pre-treatment.
Group II: Part I: Dose-escalation of RO7122290Experimental Treatment3 Interventions
The dose-escalation of RO7122290 will use a QW dosing schedule of RO7122290 in combination with a Q3W dosing interval for cibisatamab with obinutuzumab pre-treatment. The starting dose for RO7122290 will be 35 mg, which represents the human equivalent dose for the minimal pharmacologically active dose (1 mg/kg) in mice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Cibisatamab
2019
Completed Phase 1
~50
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include immunotherapy and bispecific antibodies. Immunotherapy, such as immune checkpoint inhibitors, enhances the body's immune response against cancer cells.
Bispecific antibodies, like Cibisatamab, bind to two different antigens—CEACAM5 on cancer cells and CD3 on T cells—bringing them together to stimulate a targeted immune response. These treatments are significant for colorectal cancer patients as they offer a more precise and potentially effective approach by leveraging the body's immune system to target and destroy cancer cells.
Biologic approaches to the treatment of gastrointestinal malignancy.
Biologic approaches to the treatment of gastrointestinal malignancy.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,312 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,956 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need extra oxygen or have severe trouble breathing due to my advanced cancer.I need procedures to remove fluid from around my lungs.I have a history of chronic liver disease or cirrhosis.My condition worsened within 3 months after my last standard treatment.I haven't had cancer, except for certain low-risk types, in the last 5 years.I don't have any health issues that would make it unsafe for me to take a new drug.I am fully active or restricted in physically strenuous activity but can do light work.I have or had an autoimmune disease or immune deficiency.I have had lung scarring from previous radiation treatment.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have brain metastases that are untreated or getting worse.I have had cancer spread to the lining of my brain and spinal cord.My tumor is larger than 2 cm in a critical area and has not been recently irradiated.I have trouble breathing or low oxygen levels due to lung cancer.I have fluid buildup or lesions in the lining of both my lungs.I have or had lung conditions needing steroid treatment.I have more than 10 lung spots on both sides.My lung cancer has spread in a way that shows many small spots or affects the lung's lymph channels.I haven't had major heart or stroke issues in the last 6 months.My spinal cord compression hasn't been treated or wasn't stable for 2 weeks before starting the study treatment.I have had progressive multifocal leukoencephalopathy in the past.I have pain from my cancer that isn't relieved by treatment.I frequently need procedures to remove excess fluid in my abdomen.I have fluid around my heart.I have had tuberculosis treatment within the last 3 years.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I do not have uncontrolled diseases like diabetes or lung problems that could interfere with the study.I have had a previous transplant of stem cells or an organ.I do not have any current infections or have been treated for a major infection recently.I do not have any health conditions that would make it unsafe for me to take a new drug.I haven't had major surgery or serious injury in the last 28 days and don't expect to need major surgery soon.I haven't had cancer treatment, like chemo, in the last 28 days.I have not used specific immune therapies unless approved by the trial sponsor.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.My side effects from cancer treatment are mild, except for hair loss or mild nerve pain.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.I am currently taking medication to prevent blood clots.My cancer is a type of colon or rectal cancer confirmed by a lab test.My cancer has spread widely and cannot be treated with surgery or radiation alone.My tumor is stable or has low instability according to lab tests.My tumor shows high CEACAM5 levels based on a specific test.My kidney function is normal or nearly normal.My organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Part II: Dose-expansion of RO7122290
- Group 2: Part I: Dose-escalation of RO7122290
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.
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