Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors
NCT05075993 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 352
Last updated 2025-12-26
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:
Conditions
- Metastatic Esophageal
- Gastric Cancer
- Metastatic Head and Neck Carcinoma
- Metastatic Hepatocellular Carcinoma
- Metastatic HPV Related Solid Tumors
- Metastatic Ovarian Carcinoma
- Metastatic Soft Tissue Sarcoma
- Metastatic Uveal Melanoma
Interventions
- DRUG
-
LVGN3616 + LVGN6051 + Nab-Paclitaxel
Given by IV, Given by PO
- DRUG
-
LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide
Given by IV, Given by PO
- DRUG
-
LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel
Given by IV, Given by PO
- DRUG
-
LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide
Given by IV, Given by PO
Sponsors & Collaborators
-
Lyvgen Biopharma Holdings Limited
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Siqing Fu · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-12
- Primary Completion
- 2027-02-02
- Completion
- 2027-02-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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