Clinical trialPhase 1Withdrawn
Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors
- Outcome
- Stopped earlyNo participants enrolled (Enrollment)
- Phase
- Phase 1
- Status
- Withdrawn
- Study type
- Interventional
- Start
- 14 December 2022
- Expected end
- 14 December 2022
- Enrollment
- 0 participants
- Sites
- 0
- Primary outcomes
- To establish the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of ZN-c3 .; To establish the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ZN-c3 and bevacizumab.
- Sponsor
- Other
- Results posted
- No
- Last update
- 15 June 2023
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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).