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ADG126 + Pembrolizumab for Advanced Cancer
Study Summary
This trial is testing a new combination drug regimen for safety, tolerability, how it is processed by the body, and its ability to provoke an immune response in patients with advanced 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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- My cancer has spread to my brain or spinal cord.I am not on high doses of steroids or other immune-weakening medicines.I have received a transplant from another person.I do not have any ongoing infections needing antibiotics or unmanaged asthma/COPD.I have not had major surgery in the last 4 weeks.My advanced cancer has not responded to standard treatments.I am fully active or restricted in physically strenuous activity but can do light work.I have never received immunotherapy.My organs are working well.I am 18 years old or older.I have a tumor biopsy taken within the last 2 years or can provide a new one.I got a COVID-19 vaccine within the last week or a live vaccine in the last month.I can provide tumor samples before treatment. After treatment samples are optional but preferred if I have MSS-CRC or NSCLC and have tried anti-PD-1/L1.I have been treated with anti-CTLA-4 therapy before.
- Group 1: ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has ADG126 been endorsed by the Federal Drug Administration?
"ADG126's safety profile has been deemed as a 1 due to its Phase 1 status, which implies that there is limited evidence of its efficacy and minimal data regarding safety."
What main goals is this trial attempting to achieve?
"Merck Sharp & Dohme LLC, the primary sponsor of this study, has outlined a few objectives to be measured over 9 months. These include dose-limiting toxicity (DLT) and recommended phase 2 dosing (RP2D) in combination with pembrolizumab. Additionally, secondary outcomes like time to maximum concentration (Tmax), area under the time concentration curve from zero to infinity (AUC0-inf), as well as median survival times will also be assessed."
How many individuals have been recruited for this trial thus far?
"Affirmative. Clinicaltrials.gov documents indicate that this medical trial, which first appeared on June 15th 2022, is actively recruiting participants. The study requires 102 people to be recruited from 2 distinct clinical sites."
Is this clinical experiment open for enrollment?
"Affirmative, the listing on clinicaltrials.gov alludes to this experiment being open for recruitment at present. The trial was initially posted on June 15th 2022 and has been updated recently on July 22nd 2022. There is need for 102 participants distributed across two research sites."
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