Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Melanoma

Stomach Neoplasms

Sarcoma

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Intraocular Melanoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Cyclophosphamide

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

given in combination with other drugs to patients with cancers that are advanced, relapsed (have come back), refractory (have not responded to treatment), or metastatic (have spread).

LVGN3616 + LVGN6051 + Nab-Paclitaxel

LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide

LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel

LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide

Siqing Fu

Siqing Fu, MD

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:

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 of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors

Lyvgen Biopharma Holdings Limited

M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for metastatic hpv related solid tumors