AVZO-1418 in Locally Advanced or Metastatic Solid Tumors

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and tolerability of an experimental drug called AVZO-1418 for the treatment of locally advanced solid tumors (cancers that have grown to a serious stage and form solid lumps in the body) or metastatic solid tumors (cancers that have spread from their original site to other parts of the body and form solid lumps). AVZO-1418 will be tested alone or in combination with other drugs (pembrolizumab or osimertinib) to determine the best dose of AVZO-1418 to continue using in this study and future studies. Researchers also aim to learn whether the drugs can help treat advanced or metastatic solid tumors and how the body absorbs, distributes, and gets rid of AVZO-1418. In addition, the study will examine whether the immune system reacts to these drugs and how AVZO-1418 functions in the body. AVZO-1418 works by blocking specific receptors on the cancer cell, leading to the death of the cancer cell. Pembrolizumab is a type of medication called an immunotherapy, which strengthens the immune system or helps the immune system to find cancer cells and attack them. Osimertinib works by blocking specific genetic mutations (EGFR mutations) in lung cancer cells to stop their growth. Pembrolizumab and osimertinib are approved by the U.S. Food and Drug Administration (FDA) for the treatment of various types of cancers, but their use in this study is considered experimental.


Eligibility

  • * Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \> 3 months.
  • * Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications:
  • o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).
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Where can I participate?

  • CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan
  • CS Cancer at The Angeles Clinic and Research Institute : Shannon Cyhan


More about this Clinical Trial

What is the full name of this clinical trial?

AVZO-1418-1001: A phase 1/2, first-in-human study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of AVZO-1418 as a single agent and in combination therapy in patients with locally advanced or metastatic solid tumors

Study Details
Disease Type/Condition

Breast, Larynx, Lung, Other Urinary

Principal Investigator

Reckamp, Karen

Co-Investigators

Andrew Hendifar, Cathie T Chung, Erwin Grussie, Inderjit Mehmi, Jun Gong, Justin Moyers, Kamya Sankar, Kristopher Wentzel, Omid Hamid

Age Group

Adult

Phase

I/II

IRB Number

STUDY00004325

ClinicalTrials.gov ID

NCT07038343

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Shannon Cyhan

Email
Shannon.Cyhan@cshs.org
Study Detail
Disease Type/Condition

Breast, Larynx, Lung, Other Urinary

Principal Investigator

Reckamp, Karen

Age Group

Adult

Phase

I/II

IRB Number

AVZO-1418-1001

ClinicalTrials.gov ID

NCT07038343

Key Eligibility
ClinicalTrials.gov

Contact
Name

Shannon Cyhan

Email
Shannon.Cyhan@cshs.org