A Phase I Study of XL092 with Immunotherapy in People with Solid Tumors

Share

Full Title

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advance or Metastatic Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug XL092 that can be given safely with immunotherapy drugs in people with advanced solid tumors that have come back or continued to grow despite treatment. Immunotherapy drugs boost the ability of the immune system to find and kill cancer cells.

XL092 blocks a protein that fuels cancer growth and other proteins that prevent the immune system from detecting cancer cells. Researchers believe giving XL092 with immunotherapy medications may make them more effective against cancer than they are on their own.

All participants in this study will receive XL092 and nivolumab immunotherapy. In addition, some patients will also receive ipilimumab immunotherapy. XL092 is taken orally (by mouth) and the immunotherapies are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have an inoperable or metastatic solid tumor that has come back or continued to grow despite treatment.
  • The serious side effects of previous therapies must go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Neil Shah at 646-422-4468.

Protocol

22-246

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05176483