DKN-01 in Combination With Tislelizumab ± Chemotherapy in Gastric or Gastroesophageal Junction Adenocarcinoma

What is the Purpose of this Study?

This study focuses on people who have advanced gastric or gastroesophageal junction (GEJ) cancer. The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called DKN-01 combined with another experimental drug, tislelizumab, or DKN-01 combined with tislelizumab and 2 approved drugs, capecitabine and oxaliplatin (referred to as CAPOX). Researchers aim to determine the effects that the drugs have on patients and their cancer. Patients with certain cancers including stomach and esophageal cancers have been shown to have high levels of a protein called DKK1 in their tumors, which has been shown to suppress the body’s immune system response to cancers. DKK1 also helps in spreading the cancer cells outside the tumor to other parts of the body. DKN-01 blocks DKK1 and has been shown to slow the growth of some cancers in laboratory studies. The combination of the drugs used in this study is investigational.


Eligibility

  • Inclusion:
  • Part A \& C:
  • 1. No previous therapy for cancer. Patients may have received prior neoadjuvant or adjuvant therapy as long it was completed without disease recurrence for at least 6 months since last treatment.
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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

What is the full name of this clinical trial?

DEK-DKK1-P205: A Phase 2a, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Study Details
Disease Type/Condition

Esophagus

Principal Investigator

Chiu, Vi K.

Co-Investigators

Andrew Horodner, Ani Balmanoukian, Cathie T Chung, David Chan, Hugo Hool, Inderjit Mehmi, Iryna Singh, Justin Moyers, Kristopher Wentzel, Navid Hafez, Omid Hamid, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey

Age Group

Adult

Phase

II

IRB Number

STUDY00000782

ClinicalTrials.gov ID

NCT04363801

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Esophagus

Principal Investigator

Chiu, Vi K.

Age Group

Adult

Phase

II

IRB Number

DEK-DKK1-P205

ClinicalTrials.gov ID

NCT04363801

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org