NCT05082025

Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of copanlisib in combination with fulvestrant in advanced hormone receptor-positive (HR+) solid tumors harboring alterations that activate the Phosphatidylinositol-3 kinase (PI3K) pathway.

Detailed description

Part 1: Dose confirmation: Primary Objective: • To evaluate the safety, tolerability, and dose-limiting toxicities (DLT) of copanlisib 60 mg administered intravenously (IV) on Days 1, 8 and 15 in combination with fulvestrant 500 mg administered intramuscularly (IM) on Day 1 and Day 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle to confirm the recommended phase 2 doses (RP2D) of the combination therapy. Secondary objective: * To assess the efficacy of copanlisib administered in combination with fulvestrant as outlined in Part 2 by evaluating the objective response rate (ORR). * To evaluate additional efficacy measures such as progression-free survival (PFS) and overall survival (OS) of copanlisib in combination with fulvestrant. Exploratory Objectives: • To investigate target engagement, clonal evolution, and mechanisms of resistance using tissue and liquid biopsies utilizing circulating tumor DNA (ctDNA) as outlined in Part 2. Part 2: Dose expansion: Primary objectives: • To assess the efficacy of copanlisib administered in combination with fulvestrant as outlined above by evaluating the objective response rate (ORR). Patients enrolled for Part 1 will be included in this efficacy analysis. Secondary Objectives: * To evaluate additional efficacy measures such as PFS and OS of copanlisib in combination with fulvestrant. * To evaluate the safety and tolerability of copanlisib in combination with fulvestrant. Exploratory Objectives: • To investigate target engagement, clonal evolution, and mechanisms of resistance using tissue and liquid biopsies utilizing ctDNA.

Conditions

• Endometrial Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Copanlisib	Given by IV
DRUG	fulvestrant	Given by IM

Timeline

• Start date: 2022-09-27
• Primary completion: 2024-05-03
• Completion: 2025-12-12
• First posted: 2021-10-18
• Last updated: 2026-01-09
• Results posted: 2025-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study