A Phase 3 Study to Evaluate MK-2870 in Advanced/Metastatic Gastroesophageal Adenocarcinoma

JRCT ID: jRCT2031240133

Registered date:03/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma
• Date of first enrollment: 12/06/2024
• Target sample size: 36
• Countries of recruitment: Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Israel,Japan,Italy,Japan,Malaysia,Japan,Mexico,Japan,Peru,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkiye,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Arm 1 - MK-2870 at a dose of 4 mg/kg IV on Days 1, 15, and 29 of every 42-day cycle
Arm 2 - Treatment of Physician's Choice including either trifluridine-tipiracil (35 mg/m2 po bid on Days 1 to 5 and 8 to 12 of every 28-day cycle), irinotecan (150 mg/m2 IV on Days 1 and 15 of every 28-day cycle), paclitaxel (80 mg/m2 IV on Days 1, 8, and 15 of every 28-day cycle), or docetaxel (75 mg/m2 IV on Day 1 of every 21-day cycle).

Outcome(s)

• Primary Outcome: Overall Survival (OS)

Secondary Outcome

-Progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR)
-Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
-Duration of response (DOR) per RECIST 1.1 as assessed by BICR
-Adverse events (AEs), Study intervention discontinuations due to AEs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Has a histologically-or cytologically-confirmed diagnosis of advanced, unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma.
-Has received, and progressed on, at least 2 prior chemotherapy and/or immunotherapy regimens.
-Participants are eligible regardless of human epidermal growth factor receptor-2 (HER2) status. Participants who are HER2+ must have previously received trastuzumab.
-Has adequate organ function.
-Has provided tumor tissue sample for determination of trophoblast cell-surface antigen 2 (TROP2) status by the central laboratory before randomization for stratification.
-Participants who have AEs due to previous anticancer therapies must have recovered to Grade <=1 or baseline (except for alopecia and vitiligo). Participants with endocrine related AEs who are adequately treated with hormone replacement therapy are eligible.
-Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology.
-Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days before randomization.
-Has ability to swallow oral medication for those who may receive trifluridine-tipiracil.

Exclude criteria

-Has experienced weight loss >20% over 3 months before the first dose of study intervention.
-Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
-Has Grade >=2 peripheral neuropathy.
-Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
-Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval (QTcF) to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.
-Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before the first dose of study intervention.
-Has received prior treatment with a trophoblast antigen 2(TROP2) targeted antibody-drug conjugate (ADC), a topoisomerase 1 inhibitor based, and/or a topoisomerase 1 inhibitor-based chemotherapy.
-Has received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.
-Has received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis.
-Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
-Is currently receiving a strong and/or moderate inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting MK-2870 is 2 weeks.
-Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
-Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
-Has known active CNS metastases and/or carcinomatous meningitis.
-Has an active infection requiring systemic therapy.
-Has a history of human immunodeficiency virus (HIV) infection.
-Has concurrent active hepatitis B (defined as hepatitis B surface antigen (HBsAg) reactive and/or detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA)) and/or hepatitis C (defined as anti-hepatitis C virus (HCV) antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection or a known history of hepatitis B and/or C infection.
-Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention.
-Has severe hypersensitivity (Grades >=3) to MK-2870, any of its excipients, and/or to another biologic therapy.

Related Information

• Primary Sponsor: Koh Yasuhiro
• Secondary ID(s): NCT06356311