Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 12:57 AM
NCT ID:
NCT05075993
Brief Summary:
This is an investigator-initiated industry-supported phase 1 clinical trial conducted in the phase 1 clinic at The University of Texas MD Anderson Cancer Center who will hold the Investigational New Drug (IND). Lvygen Biopharma will provide as investigational supply LVGN3616, LVGN6051 and LVGN7409 at no cost to the patients on this study. This study will explore antitumor activity of four LVGN3616 and LVGN6051 based regimens in seven selected tumor types:
Detailed Description:
Primary Objectives:
1. To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LVGN3616 and LVGN6051 ± LVGN7409 in combination with nab-paclitaxel or bevacizumab and cyclophosphamide (4 individual regimens).
2. To evaluate antitumor activity of LVGN3616 and LVGN6051 ± LVGN7409 in combination with nab-paclitaxel or bevacizumab and cyclophosphamide (16 specific cohorts according to disease type and regimen).
Secondary Objectives:
* To assess survivals.
* To explore potential baseline biomarkers.
* To explore patient-reported outcomes (PRO).
Study:
NCT05075993
Study Brief:
Protocol Section:
NCT05075993