Phase 1 / 2 Study of AGEN2034 in Advanced Tumors and Cervical Cancer

Summary

Participation Requirements

Description

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 mg/kg administered every 2 weeks Part A2: 6 and 10 mg/kg every 3 weeks Each subject will stay on the dose level and schedule assigned at tria...

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 mg/kg administered every 2 weeks Part A2: 6 and 10 mg/kg every 3 weeks Each subject will stay on the dose level and schedule assigned at trial entry. Subjects 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 subject of each cohort will be observed for 16 days (i.e., ? 48 hours after second dose) for occurrence of DLT before the second subject is administered trial medication. Thereafter, within each cohort, consecutively enrolled subjects may initiate treatment ? 48 hours after the prior enrolled subject 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 subjects at 6 mg/kg every 3 weeks, followed by open enrollment of 10 subjects 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 subjects in dose escalation may initiate treatment ? 48 hours after the prior enrolled subject initiated treatment. For cohorts in dose escalation, concurrent with the 3+3 dose escalation schema, additional subjects will be backfilled to lower dose levels to ensure that each cohort enrolls a total of 10 subjects. Subjects enrolled to backfill cohorts may be enrolled simultaneously, without sequential dosing (i.e., not required to wait 48 hours between 2 subjects). These additional subjects at each dose level will have the purpose of generating additional safety, PK, and receptor occupancy data, and will not undergo formal DLT observation. Phase 2: Dose Expansion To further characterize safety and efficacy, subjects with recurrent, unresectable, or metastatic cervical cancer will be enrolled in Phase 2 and receive the RP2D of AGEN2034 (3 mg/kg every 2 weeks) 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. An SMC will assess safety, and an Independent Data Monitoring Committee (IDMC) will evaluate safety and efficacy.

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