AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. ≥18 years at the time consent is signed. 2. Ability to provide written informed consent for the study. 3. ECOG PS of 0 or 1. 4. 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. 5. 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 \[C1D1\]) including: ANC\> 1500/ul Platelet count\>100,000 Hb\>9 g/dl Calculated creatinine clearance\> 50 mL/min Total bilirubin greater than or equal to 1.5 x ULN or direct bilirubin greater than or equal to ULN for participants with total bilirubin \> 1.5 x ULN PT INR \> 1.5 x ULN unless on anticoagulation Albumin \> 3g/dl 6. Life expectancy of ≥12 weeks, per treating investigator's judgment. 7. For Melanoma participants: Participants with unresectable or me