A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)

Conditions

• Gastroesophageal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab tirumotecan — BIOLOGICAL
  Participants will receive sacituzumab tirumotecan as 4mg/kg IV infusion on days 1, 15, and 29 of every 42-day cycle.
• Trifluridine-Tipiracil — DRUG
  Trifluridine-tipiracil will be administered at 35 mg/m\^2 as tablet orally twice a day on days 1-5 and 8-12 of every 28-day cycle.
• Irinotecan — DRUG
  Irinotecan will be administered at a dose of 150 mg/m\^2 by IV infusion on days 1 and 15 of every 28-day cycle.
• Paclitaxel — DRUG
  Paclitaxel will be administered at a dose of 80 mg/m\^2 by IV infusion on days 1, 8 and 15 of every 28-day cycle.
• Docetaxel — DRUG
  Docetaxel will be administered at a dose of 75 mg/m\^2 by IV infusion on day 1 of a 21-day cycle.
• Rescue medications — DRUG
  Participants are required to receive prophylactic mouthwash (steroid mouthwash \[dexamethasone or equivalent\] is highly recommended) to mitigate the onset and severity of stomatitis or oral mucositis. Additionally, participants may receive mucoadhesive hydrogel and oral nystatin suspension or other topical antifungal agents. Additional recommended rescue medications are histamine-1 (H1) receptor antagonist, H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, at the investigator's discretion.
• Supportive care measures — DRUG
  Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.

Study Details

This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS).

Key Dates

Start date

May 3, 2024

Status verified

Feb 2026

Primary completion

Jan 4, 2027

Completion

May 6, 2027

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sacituzumab tirumotecan
  Participants will receive sacituzumab tirumotecan at a dose of 4mg/kg by intravenous (IV) infusion on days 1, 15, and 29 of every 42-day cycle.
• Active Comparator: Treatment of Physician's Choice (TPC)
  TPC include either trifluridine-tipiracil (35 mg/m\^2 orally (PO) twice a day (BID) on days 1 to 5 and 8 to 12 of every 28-day cycle), irinotecan (150 mg/m\^2 IV on days 1 and 15 of every 28-day cycle), paclitaxel (80 mg/m\^2 IV on days 1, 8, and 15 of every 28-day cycle), or docetaxel (75 mg/m\^2 IV on day 1 of every 21-day cycle).

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to ~ 31 months ]

Locations (17)

Find similar trials in Gilbert, AZ

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