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Monoclonal Antibodies
IGM-7354 for Cancer
Phase 1
Waitlist Available
Research Sponsored by IGM Biosciences, 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 study duration of approximately 29 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it's safe, tolerable and effective. Patients with relapsed/refractory tumors will be monitored for 90 days after taking the drug.
Who is the study for?
Adults over 18 with advanced solid tumors that standard treatments can't cure or aren't tolerated. They must have stopped previous cancer therapies at least 2 weeks before, be in fairly good health (ECOG status of 0 or 1), and agree to tumor biopsies. Those with certain immune conditions, recent major surgeries, untreated brain metastases, or severe allergies to monoclonal antibodies can't join.Check my eligibility
What is being tested?
IGM-7354 is being tested for safety and how the body processes it in adults whose cancers haven't responded to other treatments. The trial has two parts: finding the right dose and then seeing its effects on a larger group. Participants will receive IGM-7354 during treatment periods followed by a safety check-up after their last dose.See study design
What are the potential side effects?
Since this is an early-stage trial for IGM-7354, specific side effects are not yet fully known but may include typical reactions related to immune-based therapies such as inflammation in organs, infusion-related reactions, fatigue, allergic responses, and potential impacts on organ function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study duration of approximately 29 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study duration of approximately 29 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD
Secondary outcome measures
Anti-drug antibodies (ADAs) of IGM-7354
Area Under the Curve (AUC) of IGM-7354
Clearance (CL) of IGM-7354
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: IGM-7354 Single-Agent Dose Expansion Serial BiopsyExperimental Treatment1 Intervention
IGM-7354 will be administered intravenously as a single agent and patients will undergo pre-treatment and on-treatment biopsies.
Group II: IGM-7354 Single-Agent Dose EscalationExperimental Treatment1 Intervention
IGM-7354 will be administered intravenously as a single agent.
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Who is running the clinical trial?
IGM Biosciences, Inc.Lead Sponsor
7 Previous Clinical Trials
319 Total Patients Enrolled
Thomas Manley, MDStudy DirectorIGM Biosciences
6 Previous Clinical Trials
1,543 Total Patients Enrolled
Roel Funke, PhD, MPHStudy DirectorIGM Biosciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases that are either untreated or currently active.I have previously received IL-15, IL-2, or similar therapy.I received radiation for bone cancer spread within the last 2 weeks.My organs are working well.I have been diagnosed with an immune system disorder.I am over 18 years old.I am fully active or can carry out light work.I have side effects from past treatments, but they are under control with medication.It's been over 2 weeks since my last cancer treatment.I have an autoimmune disease treated with medication in the last 2 years.My advanced cancer has no standard treatments left that work or that I can tolerate.My cancer can be measured or seen on tests.I have not had major surgery in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: IGM-7354 Single-Agent Dose Escalation
- Group 2: IGM-7354 Single-Agent Dose Expansion Serial Biopsy
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.
Are there still available slots for this clinical trial?
"Affirmative. Reports on clinicaltrials.gov state that this experiment is presently looking for volunteers to participate, with the initial listing appearing on January 10th 2023 and recently updated information available as of January 25th 2023. The trial needs 50 people enrolled across two medical centres."
Answered by AI
Has the FDA sanctioned IGM-7354 Single-Agent Dose Escalation?
"Our internal evaluation gave IGM-7354 Single-Agent Dose Escalation a score of 1 due to the fact that this is an early stage trial with minimal supporting data on safety or effectiveness."
Answered by AI
How many volunteers are currently enrolled in this trial?
"Affirmative, clinicaltrials.gov hosts information demonstrating that this trial is presently seeking participants. The investigation was first posted on January 10th 2023 and most recently updated a fortnight later on the 25th of the same month. 50 patients are being recruited across 2 sites."
Answered by AI
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