Trials / Active Not Recruiting
Active Not RecruitingNCT05075993
Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 352 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-11-12
- Primary completion
- 2027-02-02
- Completion
- 2027-02-02
- First posted
- 2021-10-13
- Last updated
- 2025-12-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05075993. Inclusion in this directory is not an endorsement.