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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05075993
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Gastric Cancer
  • Metastatic Esophageal
  • Metastatic HPV Related Solid Tumors
  • Metastatic Head and Neck Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Metastatic Ovarian Carcinoma
  • Metastatic Soft Tissue Sarcoma
  • Metastatic Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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:

Key Dates

First listed
Oct 13, 2021
Start date
Nov 12, 2021
Status verified
Jun 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
352 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A: LVGN3616 + LVGN6051 + Nab-Paclitaxel
    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).
  • Experimental: Regimen B: LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide
    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).
  • Experimental: Regimen C: LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel
    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).
  • Experimental: Regimen D: LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide
    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).

Primary Outcome Measure

To establish the maximum tolerated dose (MTD)/recommended. [ Time Frame: through study completion, an average of 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
M D Anderson Cancer Center· Houston, TX

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