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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically confirmed extensive SCLC or poorly differentiated NEC of any other origin, relapsed after at least 1 systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 26 months
Awards & highlights
Study Summary
This trial will assess the safety, effects and potential anti-tumor activity of a drug for advanced stage small cell lung cancer and neuroendocrine carcinoma.
Who is the study for?
This trial is for adults with advanced small cell lung cancer or neuroendocrine carcinoma who have relapsed after at least one systemic therapy. They should be able to live more than 12 weeks, be relatively active (ECOG status of 0 or 1), and have organs functioning well enough for treatment. Pregnant women can't participate, and participants must use contraception.Check my eligibility
What is being tested?
The study tests RO7616789's safety and how it affects the body and tumors in patients with certain cancers. It has three parts: increasing doses to find a safe level (Dose Escalation) and then giving that dose to more people (Dose Expansion).See study design
What are the potential side effects?
Possible side effects include typical reactions related to immune therapies such as inflammation in different parts of the body, infusion-related reactions, fatigue, changes in blood counts, increased risk of infections, and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My small cell lung cancer or neuroendocrine cancer has returned after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 26 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 26 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 and 3: Number of Participants with Adverse Events and Serious Adverse Events
Part 3: Disease Control Rates as Determined by the Investigator
+4 moreSecondary outcome measures
Part 1 and 2: DOR as Determined by the Investigators
Part 1 and 2: Disease Control Rates as Determined by the Investigator
Part 1 and 2: ORR as Determined by the Investigators
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 3: Dose ExpansionExperimental Treatment2 Interventions
Based on emerging data from Part 1 and 2, one or more dosing regimens will be further investigated in Part 3.
Group II: Part 2: RO7616789 Q3W: Dose EscalationExperimental Treatment2 Interventions
Participants will receive a fixed dose of RO7616789, at a dose determined in Part 1, intravenously once every 3 weeks (Q3W) on Day 1 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored.
Group III: Part 1: RO7616789 QW: Dose EscalationExperimental Treatment2 Interventions
Participants will receive a fixed dose of RO7616789 intravenously once weekly (QW) per dose level on Day 1, 8, and 15 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,090,055 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,772 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have a negative pregnancy test.I have had a stem cell or organ transplant in the past.I am fully active or restricted in physically strenuous activity but can do light work.I do not have a history of brain cancer, untreated brain metastases, or major neurological conditions.My blood and organs are functioning well.I have had a severe immune reaction to previous cancer immunotherapy.I have available tumor samples preserved in a specific way for testing.You have tested positive for HIV.I stopped an immune therapy due to a severe side effect, not including simple enzyme increases.My small cell lung cancer or neuroendocrine cancer has returned after treatment.You have a tumor that can be measured using specific guidelines called RECIST Version 1.1.My spinal cord compression hasn't been treated with surgery or radiation.You are expected to live for at least 12 more weeks.You have tested positive for hepatitis B surface antigen or hepatitis B core antibody.My diabetes is not well-managed, with high blood sugar or A1c levels.I have not been treated with anti-CD137, anti-CD3, or DLL3 targeted therapies.Your heart's electrical activity, measured by a test called an ECG, shows abnormal results or your QT interval is longer than 470 milliseconds.I am currently taking medication that can affect my heart's rhythm.I haven't had any cancer treatment, including chemotherapy or radiotherapy, in the last 21 days.I have not received a live vaccine within the last 4 weeks.You have a serious autoimmune disease that is currently active or has been a problem in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: RO7616789 Q3W: Dose Escalation
- Group 2: Part 1: RO7616789 QW: Dose Escalation
- Group 3: Part 3: Dose Expansion
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.
How many subjects are participating in this research project?
"Affirmative. According to information housed on clinicaltrials.gov, the medical trial is recruiting participants, having first been posted on January 23rd 2023 and last updated February 17th of that same year. 168 individuals are required at a single site for this study."
Answered by AI
Has the FDA sanctioned Part 2: Dose Escalation of this medication?
"Our team has assigned Part 2: Dose Escalation a score of 1 as this is an early-phase trial, and therefore there is minimal data available to support its safety or efficacy."
Answered by AI
Is this research project still recruiting participants?
"According to clinicaltrials.gov, the research team is currently recruiting volunteers for this trial that was first posted on January 23rd 2023 and has been recently updated on February 17th 2023."
Answered by AI
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