AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously.
Dosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.
Histologically confirmed unresectable, locally advanced, or metastatic solid tumors.
Refractory to or relapsed after all standard therapies known to provide proven clinical benefit, unless the patient is not a candidate for standard treatment, there is no standard treatment, or the patient refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit
Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor
Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): Systemic cytotoxic chemotherapy: ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C); Biologic therapy (eg, antibodies): ≥ 3 weeks; Small molecule therapies: ≥ 5 × half-life
Colorectal cancer patients with an unresected primary colorectal tumor and non-small-cell lung cancer with predominant squamous histology (ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed and approved by Sponsor
Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable and/or asymptomatic CNS metastases allowed)
Have not recovered to ≤ Grade 1 or baseline from all AEs due to previous therapies (patients with ≤ Grade 2 neuropathy, endocrine-related irAEs, or other AEs may be eligible after discussion with the Sponsor)
Has an active vasculitis that has required systemic treatment in the past 2 years prior to starting study treatment
Sequential
AGX101
DrugAntibody Drug Conjugate
Acceptable maximum tolerated dose for participants
Maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of AGX101 will be characterized
Number of participants with adverse events
Evaluation of the incidence, severity, and duration of adverse events
Terminal elimination half life (PK)
Determination of the terminal elimination half-life (t½)
AUC (PK)
Determination of the AUC in 1 dosing interval
Cmax (PK)
Determination of the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state
Number of Participants with Antidrug Antibodies (ADA) to AGX101
Incidence and titers of ADA will be measured
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