RecruitingPhase 1NCT07027488

AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

An Open-Label, Phase 1 Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AB821 in Adult Participants With Locally Advanced or Metastatic Melanoma and Other Solid Tumors


Sponsor

Yale University

Enrollment

50 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a first-in-human, open-label, nonrandomized, single center Phase 1 dose-escalation study to assess the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of AB821 monotherapy given every 2 weeks (Q2W) in participants with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors. Immune-responsive solid tumors are defined as those for which immune checkpoint inhibitors form part of the standard-of-care therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new investigational drug called AB821 in adults with advanced or metastatic solid tumors (cancers that have spread and cannot be surgically removed). **You may be eligible if:** - You are 18 or older - You have an advanced or metastatic solid tumor - Your cancer has progressed despite available standard treatments - You are in good physical health (able to perform most daily activities) - Your blood counts, kidney, and liver function are within acceptable ranges - You are willing to use contraception if applicable **You may NOT be eligible if:** - You have active brain metastases (cancer spread to the brain) that are unstable - You have a serious active infection or immune system disorder - You are pregnant or breastfeeding - Your organ function (kidney, liver, blood) is significantly impaired - You have had certain prior treatments that would interfere with this drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAB821

AB821 will be administered via IV infusion using weight-based dosing. AB821 will be administered over 30 minutes +/- 10 minutes. Participants will receive AB821 on Day 1 of each 14 day cycle for up to two years.


Locations(1)

Yale University

New Haven, Connecticut, United States

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NCT07027488


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