ORION-1: A phase 1/2, first-in-human study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of AVZO-023 as a single agent, and in combination with AVZO-021 and/or endocrine therapy in patients with advanced solid tumors

Condition studied

Advanced Cancer

Investigational medicinal product(s)

Every trial of AVZO-021, Letrozole and Fulvestrant across our registers →

Eligibility

Primary endpoint

Phase 1: Dose Escalation: Number of patients with a dose-limiting toxicity (DLT) during the first cycle., Phase 1: Dose Escalation: Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)., Phase 1: Dose Escalation: Changes in clinical laboratory abnormalities including hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, reductions, and dose intensity., Phase 1: Dose Escalation: MTD and/or preliminary RP2D., Phase 2: Dose Expansion: Objective response rate (ORR)

Endpoint detail

Phase 1: Dose Escalation: Objective response rate (ORR), Phase 1: Dose Escalation: Duration of response (DOR), Phase 1: Dose Escalation: Clinical benefit rate (CBR), Phase 1: Dose Escalation: Disease control rate (DCR), Phase 1: Dose Escalation: Progression-free survival (PFS), Phase 1: Dose Escalation: Overall survival (OS), Phase 1: Dose Escalation: Maximum observed plasma concentration (Cmax), Phase 1: Dose Escalation: Time to maximum observed plasma concentration (Tmax), Phase 1: Dose Escalation: Elimination half-life (t½), Phase 1: Dose Escalation: Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUClast), Phase 1: Dose Escalation: Area under the plasma concentration-time curve from time 0 to infinity (AUCinf), Phase 1: Dose Escalation: Area under the plasma concentration-time curve from time 0 to the end of the dosing period (AUCτ), Phase 1: Dose Escalation: Apparent clearance (CL/F), Phase 1: Dose Escalation: Apparent volume of distribution during terminal phase (VZ/F), Phase 1: Dose Escalation: Minimum observed plasma concentration at steady state (Cmin, ss), Phase 1: Dose Escalation: Accumulation ratio (Rac), Phase 2: Dose Expansion: RP2D, Phase 2: Dose Expansion: AEs, SAEs, changes in hematology and chemistry values, vital signs, ECGs, dose interruptions, reductions, and dose intensity, Phase 2: Dose Expansion: Duration of response (DOR), Phase 2: Dose Expansion: Clinical benefit rate (CBR), Phase 2: Dose Expansion: Disease control rate (DCR), Phase 2: Dose Expansion: Progression-free survival (PFS), Phase 2: Dose Expansion: Overall survival (OS), Phase 2: Dose Expansion: Sparse PK concentrations