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Monoclonal Antibodies
Eciskafusp Alfa + Atezolizumab for Cancer
Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group Performance Status 0 to 1
No standard of care (SoC) (approved) treatments are available for the participant, or the participant cannot tolerate such treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until end of part 1 and part 2 (up to approximately 1.5 months)
Awards & highlights
Study Summary
This trial will study the effects of RO7284755, alone and with atezolizumab, on adults with solid tumors that may respond to checkpoint inhibition blockade. Each participant will be in the trial for up to 28 months.
Who is the study for?
This trial is for adults with advanced solid tumors that have no standard treatments available or can't tolerate them. Participants should have a life expectancy of at least 12 weeks, measurable disease, and be in relatively good health (able to perform daily activities without significant assistance). They must not have severe allergies to certain antibodies or proteins, untreated brain metastases, other active cancers, certain viral infections like HIV or hepatitis B/C, recent major surgeries or injuries.Check my eligibility
What is being tested?
The study tests Eciskafusp Alfa alone and combined with Atezolizumab in patients whose solid tumors might respond to checkpoint inhibitors. The goal is to evaluate the safety and how well these treatments shrink tumors over a maximum period of 28 months.See study design
What are the potential side effects?
Potential side effects include allergic reactions related to the immune system's response to treatment components such as chimeric/humanized antibodies. Other risks may involve complications from rapid tumor progression if present and any issues arising from pre-existing conditions that are uncontrolled.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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No standard treatments work for me or I can't tolerate them.
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My cancer cannot be removed by surgery and may have spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until end of part 1 and part 2 (up to approximately 1.5 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until end of part 1 and part 2 (up to approximately 1.5 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator Assessed Objective Response Rate according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Part 3
Percentage of Participants with Adverse Events in Part 1 and Part 2
Percentage of Participants with Dose-Limiting Toxicities in Part 1 and Part 2
+1 moreSecondary outcome measures
Area Under the Curve (AUC) for Eciskafusp Alfa
Blood Tumor Mutational Burden
Change from Baseline in Antidrug Antibody (ADA) to Eciskafusp Alfa
+14 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Eciskafusp Alfa in Combination with AtezolizumabExperimental Treatment2 Interventions
Part 2: Dose-escalation of eciskafusp alfa in combination with atezolizumab.
Group II: Eciskafusp Alfa as a Single Agent and/or with AtezolizumabExperimental Treatment2 Interventions
Part 3: Extension of eciskafusp alfa as a single agent and/or in combination with atezolizumab.
Group III: Eciskafusp Alfa as a Single AgentExperimental Treatment1 Intervention
Part 1: Dose-escalation of eciskafusp alfa as a single agent. eciskafusp alfa will be either an intravenous administration (IV) or subcutaneous administration (SC) in multiple-ascending doses.
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?
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,154 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,476 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have hepatitis B or C.I have brain metastases that have not been treated.I have another type of cancer at the same time.My cancer is quickly getting worse, threatening vital organs.I am HIV positive.I am fully active or can carry out light work.No standard treatments work for me or I can't tolerate them.I have fluid in both sides of my chest.My spinal cord compression hasn't been treated or wasn't stable for 2 weeks before starting treatment.I am not allergic to any part of the treatment, including Chinese hamster ovary cell products.I have brain metastases that don't cause symptoms and have been treated.My cancer cannot be removed by surgery and may have spread.I do not have any major health issues that could interfere with the study.I have pain from my cancer that isn't managed by medication or I have high calcium levels causing symptoms.My side effects from previous cancer treatments are mild, except for possible hair loss, nerve pain, or thyroid issues.I haven't had a major heart or stroke event in the last 28 days.I do not have any active or uncontrolled infections.I haven't had major surgery or serious injury in the last 28 days and don't expect to need major surgery soon.I have or had cancer spread to the lining of my brain or spinal cord.My heart, blood, liver, and kidneys are functioning well.I have been treated with IL-2 or IL-15, but not as part of adoptive cell therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Eciskafusp Alfa as a Single Agent
- Group 2: Eciskafusp Alfa in Combination with Atezolizumab
- Group 3: Eciskafusp Alfa as a Single Agent and/or with Atezolizumab
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.
Is recruitment still open for this experiment?
"Affirmative. Clinicaltrials.gov contains information asserting that this study, the parameters of which were first disseminated on May 4th 2020, is actively recruiting participants. Approximately 348 volunteers are being sought at a single medical facility."
Answered by AI
Is this the inaugural trial of its kind?
"At present, 350 trials for RO7284755 are live in 1646 cities and 74 countries. In 2008, Hoffmann-La Roche launched the initial clinical trial which included 720 participants and successfully achieved Phase 2 approval status. Since then, 81 more studies have been executed."
Answered by AI
Has the FDA sanctioned RO7284755 yet?
"As this is a first-phase study, the safety rating for RO7284755 was estimated to be 1 due to minimal evidence of its efficacy and protection."
Answered by AI
What ailments has RO7284755 been found to provide relief from?
"RO7284755 is commonly prescribed for small cell lung cancer (SCLC) but may also be used to address conditions such as malignant neoplasms, non-small cell lung carcinoma, and postoperative ailments."
Answered by AI
How many subjects are being observed in this experiment?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial which debuted on May 4th 2020 is currently enrolling volunteers. The most recent update was made on November 22nd 2022 and the study requires 348 individuals to be recruited from a single site."
Answered by AI
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