AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07027488
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Melanoma
  • Advanced Melanoma and Normal or Impaired

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • AB821 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 5, 2025
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AB821
    AB821 is intended to be administered as a 30-minute IV infusion every 2 weeks. Dosage is calculated per body weight.

Primary Outcome Measure

Frequency of Dose-Limiting Toxicities (DLTs) in patients with advanced melanoma [ Time Frame: From the date of enrolment to the final follow up visit, approximately two years after the first dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Jialing Zhang
[email protected]

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CT

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