A Study of AGEN2034 in Advanced Tumors and Cervical Cancer

Phase 1: Dose Escalation

Phase 1 will consist of a standard 3+3 dose escalation with the following escalating dose levels and schedules:

Part A1: 1, 3, and 10 milligrams/kilogram (mg/kg) administered every 2 weeks

Part A2: 6 and 10 mg/kg every 3 weeks

Each participant will stay on the dose level and schedule assigned at trial entry. Participants will receive AGEN2034 for a maximum of 2 years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.

A Safety Monitoring Committee (SMC) will assess safety; decide on dose-escalation and opening of backfill enrollment; define the recommended Phase 2 dose (RP2D); and determine opening of the Phase 2 cohorts.

In Part A1, the first participant of each cohort will be observed for 16 days (that is, ≥48 hours after second dose) for occurrence of dose-limiting toxicity (DLT) before the second participant is administered trial medication. Thereafter, within each cohort, consecutively enrolled participants may initiate treatment ≥48 hours after the prior enrolled participant-initiated treatment. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or the maximum planned dose level (10.0 mg/kg) is shown to be safe. The MTD is defined as the dose below which ≥2 DLTs are observed.

Once Part A1 is completed, enrollment to Part A2 will begin. If \<2 DLTs are observed in Part A1 at the maximum planned dose of 10 mg/kg every 2 weeks, open enrollment to Part A2 will begin with enrollment of 10 participants at 6 mg/kg every 3 weeks, followed by open enrollment of 10 participants at 10 mg/kg every 3 weeks. If ≥2 DLTs are observed in Part A1, at the maximum planned dose in Part A1, the standard 3+3 dose escalation will resume with Part A2 where consecutively enrolled participants in dose escalation may initiate treatment ≥48 hours after the prior enrolled participant-initiated treatment.

For cohorts in dose escalation, concurrent with the 3+3 dose escalation schema, additional participants will be backfilled to lower dose levels to ensure that each cohort enrolls a total of 10 participants. Participants enrolled to backfill cohorts may be enrolled simultaneously, without sequential dosing (that is, not required to wait 48 hours between 2 participants). These additional participants at each dose level will have the purpose of generating additional safety, pharmacokinetics, and receptor occupancy data, and will not undergo formal DLT observation.