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NGM438 + Pembrolizumab for Cancer
Study Summary
This trial is testing a new cancer drug, NGM438, as a possible treatment for advanced or metastatic solid tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I have received treatments targeting LAIR1.My bone marrow, kidney, and liver are functioning well.I am fully active or restricted in physically strenuous activity but can do light work.My side effects from previous treatments are mild or gone.My cancer did not respond or I couldn't tolerate all treatments I was eligible for.My cancer is advanced or has spread and was confirmed by a lab test.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Group 1: NGM438 Combination Dose Finding with pembrolizumab ( KEYTRUDA ® )
- Group 2: Biopsy Cohort with NGM438 Monotherapy Followed by Combination Therapy with Pembrolizumab(KEYTRUDA ®)
- Group 3: NGM438 Monotherapy Dose Escalation
- 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
What is the size of the sample pool being examined in this experiment?
"This trial requires 71 individuals who meet the required conditions to join. Those interested in participating can do so from different medical centres, such as Henry Ford Health System (Detroit MI) and Yale Cancer Center (New Haven CT)."
Does this clinical trial currently have openings for participation?
"This medical trial is open for recruitment, as indicated by the clinicaltrials.gov record which was initially posted on May 11th 2022 and modified lastly on October 6th of that same year."
Has NGM438 been cleared by the Food and Drug Administration?
"NGM438's safety is judged at a 1 on our team's scale, as this Phase 1 trial has only limited evidence supporting its efficacy and security."
How many locations are currently facilitating this experiment?
"Currently, 5 distinct clinical trial sites are recruiting patients. Those locations encompass Detroit and New Haven as well as Houston with an additional 5 other cities included in the study. Enrollees should select a site that is most proximate to them to reduce travel demands."
What aims is this clinical research seeking to accomplish?
"The primary aim of this 24-month research project is to monitor the alterations in CD163, a pharmacodynamic biomarker, within paired tumor tissue from participants enrolled into the Biopsy Cohort. Secondary objectives include assessing occurrences and titres of anti-drug antibodies against NGM438 over 6 cycles; noting Tmax (time to reach peak serum concentration) on specified days during each cycle; and calculating systemic clearance of NGM438 also at predetermined points throughout each cycle."
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