AB821 for Advanced Melanoma and Other Solid Tumors
This study is testing a new drug called AB821 in adults with locally advanced or metastatic (spread to other parts of the body) melanoma and other solid tumors that have responded to immune checkpoint inhibitors in the past. The main goal is to understand the safety of AB821, including any side effects, and to find the best dose. Researchers will also look at how the drug moves through your body, how your immune system reacts to it, and if it shows any signs of shrinking tumors. AB821 works by targeting specific pathways (mechanisms) in the body, such as PD-1 and PD-L1, which are involved in how cancer cells hide from the immune system. You would receive AB821 through an IV infusion for up to two years. This is a first-in-human study, meaning it's the first time AB821 is being given to people.
- Study design
- This is a Phase 1, open-label (you and your doctors will know what treatment you are receiving), non-randomized study. It plans to enroll 50 participants to find the safest and most effective dose of AB821.
- What's involved
- You would receive AB821 via IV infusion on Day 1 of a 14 or 21-day cycle for up to two years. You would also have follow-up visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed from the date of enrollment to the final follow-up visit, which is approximately two years after your first dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Harriet Kluger, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- Frequency of Dose-Limiting Toxicities (DLTs) in patients with advanced melanomaFrom the date of enrolment to the final follow up visit, approximately two years after the first dose
The primary objective of this outcome measure is to assess the number of participants experiencing dose-limiting toxicities (DLTs) during the study period. DLTs are specific adverse events (AEs) that are considered significant enough to prevent an increase in dose or continuation of treatment.
- Frequency of Serious Adverse Events (SAEs) in patients with advanced melanomaFrom the date of enrolment to the final follow up visit, approximately two years after the first dose
This outcome measure aims to record the number of participants who experience serious adverse events (SAEs) while receiving AB821. An SAE is defined as any event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
- Frequency of Treatment-Emergent Adverse Events (TEAEs) in patients with advanced melanomaFrom the date of enrolment to the final follow up visit, approximately two years after the first dose
This measure will track the number of participants experiencing treatment-emergent adverse events (TEAEs) during the study. TEAEs are adverse events that emerge following the start of treatment with AB821 and are not present prior to treatment or represent an exacerbation of a pre-existing condition.
- Frequency of Adverse Events of Special Interest (AESIs) in patients with advanced melanomaFrom the date of enrolment to the final follow up visit, approximately two years after the first dose
This outcome measure focuses on the number of participants who experience adverse events of special interest (AESIs). AESIs are pre-specified medical occurrences that have been identified as important to monitor due to their potential impact on the risk-benefit profile of AB821.
- Frequency of Adverse Events (AEs) Leading to Dose Interruption in patients with advanced melanomaFrom the date of enrolment to the final follow up visit, approximately two years after the first dose
The objective of this measure is to document the number of participants who experience adverse events that result in a temporary interruption of AB821 administration. The interruptions could be due to the severity of the adverse event making it necessary to halt the dosing temporarily.
- Frequency of Adverse Events (AEs) Leading to Treatment Discontinuation in patients with advanced melanomaFrom the date of enrolment to the final follow up visit, approximately two years after the first dose
This outcome measure will track the number of participants who experience adverse events leading to the permanent discontinuation of treatment with AB821. These events warrant stopping the treatment altogether to ensure participant safety.
- Frequency of Deaths in patients with advanced melanomaFrom the date of enrolment to the final follow up visit, approximately two years after the first dose
The primary objective of this measure is to record the number of participants who die during the study period, irrespective of the cause. This encompasses any deaths occurring within the timeframe of the study and helps to monitor the overall impact of the study treatment on participant mortality.