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
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.
• ≥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 \[C1D1\]) 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
• 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).
• For other tumor types: Must have a recurrent histologically or cytologically proven metastatic or locally advanced solid tumor (non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), Merkel-cell carcinoma, bladder cancer, or squamous cell carcinoma of the head and neck (SCCHN)), 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.