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Monoclonal Antibodies
ADU-1805 +/- Pembrolizumab for Cancer
Phase 1
Recruiting
Research Sponsored by Sairopa B.V.
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 through study completion, up to 2,5 years
Awards & highlights
Study Summary
This trial tests a new drug to see if it's safe and effective when used alone or with another drug.
Who is the study for?
Adults with advanced solid tumors that have not responded to standard treatments or for which no standard treatment is available can join. They must be over 18, able to consent, have a certain level of physical function (ECOG status 0 or 1), and adequate organ/marrow function. Not eligible if they have specific cancers like melanoma or brain tumors, are pregnant/breastfeeding, recently received certain therapies, suffer from severe infections or heart disease, among other exclusions.Check my eligibility
What is being tested?
The trial is testing ADU-1805 alone and combined with Pembrolizumab in patients with advanced solid tumors. It's the first time humans will receive ADU-1805; researchers want to see how safe it is and how the body processes it (pharmacokinetics). The study involves gradually increasing doses to find the right amount that's both effective and safe.See study design
What are the potential side effects?
Potential side effects include typical reactions related to monoclonal antibodies such as infusion-related reactions, immune system complications leading to inflammation in various organs, fatigue, possible allergic responses due to hypersensitivity to ingredients in ADU-1805 or similar drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 2,5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 2,5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters
Secondary outcome measures
Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab
Pharmacodynamics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab
Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Monotherapy dose escalation, IV, Q3W, multiple dose levelsExperimental Treatment1 Intervention
ADU-1805 monotherapy dose escalation
Group II: Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed doseExperimental Treatment2 Interventions
ADU-1805 plus pembrolizumab dose escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Sairopa B.V.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have melanoma, brain tumor, glioblastoma, sarcoma, or pancreatic cancer.I haven't had certain cancer treatments or drugs recently.I am currently on medication for an infection.I have received a transplant from another person.I have heart problems that affect my daily activities.I am experiencing significant side effects from previous cancer treatments.I am 18 years old or older.My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.I am fully active or can carry out light work.My organs and bone marrow are working well.I have not had major surgery recently.I have been diagnosed with or tested positive for HIV, hepatitis B, hepatitis C, or active tuberculosis.I do not have any severe illnesses that could risk my safety or prevent me from participating in the study.I have brain metastases that haven't been treated.
Research Study Groups:
This trial has the following groups:- Group 1: Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose
- Group 2: Monotherapy dose escalation, IV, Q3W, multiple dose levels
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 currently any opportunities to participate in this research?
"Affirmative. Clinicaltrials.gov affirms that this medical trial, which was published on April 3rd 2023, is currently enrolling patients. Around 90 participants need to be enrolled from three different healthcare sites."
Answered by AI
Has the United States Food and Drug Administration sanctioned a regimen of escalating dosage, intravenous administration every three weeks with multiple levels of pembrolizumab at a fixed dose?
"With limited clinical evidence regarding efficacy and safety, our Power team assessed the Combination dose escalation, IV, Q3W, multiple dose levels of pembrolizumab at fixed doses to be a score of 1."
Answered by AI
What is the uppermost patient count participating in this experiment?
"Affirmative, the info posted on clinicaltrials.gov illustrates that this research project is actively enrolling participants. It was first published on April 3rd 2023 and has been updated as recently as May 26th of the same year. 90 test subjects are required at three separate medical facilities."
Answered by AI
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