General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06356311

Background Information

The purpose of this research study is to see if MK2870 has any benefits at dose levels thought to be acceptable in earlier studies. The researchers want to find out what effects (good and bad) MK2870 has and whether treatment with MK2870 is better than a standard of care treatment of your doctor's choice.

This trial is testing MK-2870 (sacituzumab tirumotecan) in people with gastroesophageal adenocarcinoma that has progressed (become worse) after at least 2 prior treatments. This trial will compare MK-2870 to chemotherapies that are standard treatment for these cancers. The chemotherapies given in this trial are trifluridine-tipiracil, irinotecan, paclitaxel, and docetaxel.

MK-2870 is experimental. It has not been approved by the United States Food and Drug Administration (FDA) to treat any type of cancer.


The purpose of this trial is to:
o Test the safety of the trial drug, MK-2870
o See how well MK-2870 works compared to standard chemotherapy
o See if participants who get MK-2870 live longer compared to those who get standard chemotherapy

For more information, please visit: https://www.clinicaltrials.gov/study/NCT06356311

Offered At

8081 Innovation Park Drive 
Fairfax, VA 22031 
 
Principal Investigator

Jasmine Huynh, MD

Eligibility Information

  • Age ≥ 18
  • A histologically- or cytologically-confirmed diagnosis of advanced, unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma
  • Disease progression after at least 2 prior chemotherapy and/or immunotherapy regimens
  • Adequate organ function as defined by the protocol
  • Individuals who may receive trifluridine-tipiracil must have the ability to swallow oral medication
  • Additional eligibility in protocol.

Ineligibility Information

  • Pregnancy/Breastfeeding
  • History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
  • Grade ≥2 peripheral neuropathy
  • Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Prior treatment with a TROP2-targeted ADC, a topoisomerase 1 inhibitor-based ADC, and/or a topoisomerase 1 inhibitor-based chemotherapy
  • Currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
    • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded
    • Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded
      Known active CNS metastases and/or carcinomatous meningitis
  • Active infection requiring systemic therapy
  • Participants who are incapacitated are not eligible for this study
  • Additional ineligibility in protocol.