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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• ≥18 years at the time consent is signed.

• Ability to provide written informed consent for the study.

• ECOG PS of 0 or 1.

• Participants of childbearing potential must not be pregnant at enrollment and agree to comply with contraception requirements. Participants with partners of childbearing potential must also comply with contraception requirements.

• Adequate organ function as defined below. Specimens must be collected within seven days prior to the start of the study treatment (i.e., Cycle 1 Day 1 \[C1D1\])

• Life expectancy of ≥12 weeks, per treating investigator's judgment.

• For Melanoma participants: Participants with unresectable or metastatic melanoma that have progressed on or after PD 1/PD L1 checkpoint blockade (alone or with either CTLA 4 or LAG 3 checkpoint blockade).

• Note: Participants known to be BRAF V600 mutation-positive; prior therapy with BRAF±MEK inhibitor is at the treating investigator's discretion.

• For other tumor types: Must have a recurrent histologically or cytologically proven metastatic or locally advanced solid tumor, meeting each of the following:

‣ Tumor that is not amenable to curative treatment with surgery or radiation.

⁃ Tumor for which immune checkpoint inhibitors form part of standard-of-care therapy.

⁃ Participant has received at least one prior line of systemic anticancer therapy in the recurrent or metastatic setting.

• Has measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology.

Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Contact Information
Primary
Stephanie Ladd
stephanie.ladd@yale.edu
203-785-5702
Time Frame
Start Date: 2025-08-05
Estimated Completion Date: 2027-08
Participants
Target number of participants: 50
Treatments
Experimental: AB821
AB821 is intended to be administered as a 30-minute IV infusion every 2 weeks. Dosage is calculated per body weight.
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: Asher Biotherapeutics, Inc.

This content was sourced from clinicaltrials.gov

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