NCT05636111

Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.

Detailed description

Primary Objectives: * To identify dose-limiting toxicities (DLTs) and recommended phase 2 dose (RP2D) of the combination of paclitaxel/bevacizumab/lurbinectedin in women with platinum resistant ovarian cancer. * To assess macrophage counts by image cytometry in women with platinum resistant ovarian cancer treated with weekly paclitaxel/bevacizumab/lurbinectedin. Secondary Objectives: * To assess objective response (OR) and duration of response (DOR). * To assess clinical benefit rate (CBR), defined as proportion of patients with OR or stable disease (SD) \> 4 months. * To estimate progression free survival (PFS) and overall survival (OS) for at least 12 months Exploratory Objectives: --To assess differential effects from baseline, within and between patient treatment cohorts, on macrophage and hypoxia markers, CSF1/R and MHCII, plasma biomarker (VEGF, VEGFR, IL6, IL8, FGF, PDGFAA), tumor and macrophage-derived exosomes, resident macrophage populations in tissue pre-enrollment and after induction bevacizumab (CD11b +CD68, CD11b +CD14/CD15/CD33, CD11b +CD11c, MHCII, CD168+, CD4/CD8, NK, Treg) by multicolor tissue cytometry, as well as serial changes in vivo imaging such as tumor size, macrophage-specific imaging, ADC for cellularity, and DCE for vasculature.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given by (IV) vein
DRUG	Bevacizumab	Given by (IV) vein
DRUG	Lurbinectedin	Given by (IV) vein

Timeline

• Start date: 2023-07-12
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-12-05
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study