NCT05431582

Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives are to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of ZN-c3 and ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors as well to evaluate antitumor activity of ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors.

Detailed description

Primary Objectives: * To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of ZN-c3 and ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors. * To evaluate antitumor activity of ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors. Secondary Objectives: * To assess progression-free survival (PFS), overall survival (OS), and duration of response (DOR) * To explore potential biomarkers. * To explore patient reported outcomes (PRO).

Conditions

• Tumors
• Ovarian Cancer
• Breast Cancer
• Lung Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	ZN-c3	Given by PO 1 time a day with a glass (about 8 ounces) of water
DRUG	Bevacizumab	Given by vein over about 30-60 minutes on Day 1 of each cycle
DRUG	Pembrolizumab	Given by vein over 30-60 minutes on Day 1 of each cycle.

Timeline

• Start date: 2022-12-14
• Primary completion: 2022-12-14
• Completion: 2022-12-14
• First posted: 2022-06-24
• Last updated: 2023-06-15

Regulatory

• FDA-regulated drug study