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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05075993 on ClinicalTrials.gov