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Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types

Clinical Trial Details

This clinical trial is for men and women who have an advanced cancer that has not responded or has stopped responding to treatment with a class of drugs called programmed cell death protein-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) inhibitors.
   
The aim of this research study is to understand the safety and efficacy of an experiment treatment called MT-8421. This study will look at MT-8421 by itself as well as when used with another drug, a PD-1 inhibitor, called nivolumab or OPDIVO® (brand name). This is the first research study using MT-8421 in humans. MT-8421 is experimental, meaning it has not been approved for the treatment of cancer by the United States Food and Drug Administration (FDA) and is not available to the public. Nivolumab has been approved by the FDA to treat many cancers.
   
The study will happen in 2 parts: Part A and Part B. The goal of Part A is to find the highest safe and tolerable dose of MT-8421. Then, a recommended dose will be determined in Part B. Both parts of the study will evaluate how well the study treatment works at treating a participant’s cancer.

Participants will be treated with either:

  • MT-8421 intravenously (IV, through a needle in your vein or port) over 30 minutes on Day 1, Day 8, Day 15, and Day 21 of a 28-day cycle OR 
  • MT-8421 intravenously over 30 minutes on Day 1, Day 8, Day 15, and Day 21 of a 28-day cycle and nivolumab intravenously for 1 hour on Day 1 of each 28-day cycle, starting at Cycle 2. 

 Participants will be treated until their cancer gets worse, they become too sick to continue, their cancer responds and they no longer need treatment, they no longer want treatment, or their study doctor decides it is in their best interest to stop study treatment with MT-8421.
   
After study treatment is stopped, the study doctor will evaluate participants every 3 months for up to 2 years.

Key Eligibility: 
  1. Men and women who have histologically confirmed, unresectable, locally advanced or metastatic melanoma, hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), MSI-H/dMMR malignancies, urothelial carcinoma, esophageal squamous cell carcinoma, mesothelioma, squamous cell carcinoma of the head and neck (SCCHN), or cervical carcinoma not amenable to standard treatment.
  2. Prior treatment must include a PD-1 or PD-L1 inhibitor.

Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2305026098

ClinicalTrials.gov:

NCT06034860

Sponsor:

MT-8421-001

Status

Open to Enrollment

Age Group

Adult

Sponsor