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NCT06445972 · ClinicalTrials.gov registry record · Phase 1

Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)

A Phase 1 study of Esophageal Cancer and Esophageal Neoplasms, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 1
Development phase
210
Enrollment target
20
Study locations

NCT06445972: Recruiting Phase 1 study of Esophageal Cancer and Esophageal Neoplasms, sponsored by Merck Sharp & Dohme.

NCT06445972 is a Phase 1 study of Esophageal Cancer and Esophageal Neoplasms that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 210 participants, below the 497-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06445972, a Phase 1 study of Esophageal Cancer and Esophageal Neoplasms, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 1
Development phase
210 participants
Enrollment target
20
Study locations

Study Summary

This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.

Primary Outcome

DLTs are defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The percentage of participants who experience at least one DLT will be presented.

Conditions Studied

Esophageal Cancer Esophageal Neoplasms Gastroesophageal Adenocarcinoma Gastroesophageal Junction

Interventions

  • DRUG Paclitaxel
  • BIOLOGICAL Ramucirumab
  • BIOLOGICAL Sacituzumab Tirumotecan
  • DRUG Rescue Medications
  • BIOLOGICAL HER3-DXd

Study Locations (20)

Region M. de Santiago

  • FALP-UIDO ( Site 8400) - Santiago
  • Centro de Oncología de Precisión-Oncology ( Site 8404) - Santiago
  • Clínica UC San Carlos de Apoquindo ( Site 8405) - Santiago
  • Bradfordhill-Clinical Area ( Site 8401) - Santiago

New York

  • Hematology-Oncology Associates of Central NY, P.C. ( Site 8925) - East Syracuse
  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907) - New York

Arizona

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927) - Tucson

California

  • UCLA Hematology/Oncology - Santa Monica ( Site 8905) - Los Angeles

Kentucky

  • Norton Cancer Institute - Downtown ( Site 8900) - Louisville

Michigan

  • The Cancer and Hematology Centers ( Site 8912) - Grand Rapids

Pennsylvania

  • UPMC Hillman Cancer Center-UPMC ( Site 8904) - Pittsburgh

Texas

  • University of Texas MD Anderson Cancer Center ( Site 8920) - Houston

Trial Details

FieldValue
Enrollment Target 210 participants
Start Date 2024-08-07
Est. Completion 2030-08-08
Phase Phase 1
Merck Sharp & Dohme

558 total trials

What NCT06445972 shows while recruiting

NCT06445972 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 497-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (58% lower).

The record links to 4 conditions, with Esophageal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Paclitaxel is the first listed.

NCT06445972 names 20 study sites across 16 states, led by Region M. de Santiago, New York, Arizona.

Frequently Asked Questions

What is clinical trial NCT06445972 about?

NCT06445972 is a clinical study titled "Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)". This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants w...

What is the current status of trial NCT06445972?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2024-08-07. Estimated completion is 2030-08-08.

What conditions does trial NCT06445972 study?

This clinical trial studies the following conditions: Esophageal Cancer, Esophageal Neoplasms, Gastroesophageal Adenocarcinoma, Gastroesophageal Junction.

What interventions are being tested in trial NCT06445972?

The interventions under investigation include: Paclitaxel (DRUG), Ramucirumab (BIOLOGICAL), Sacituzumab Tirumotecan (BIOLOGICAL), Rescue Medications (DRUG), HER3-DXd (BIOLOGICAL).

Who is sponsoring clinical trial NCT06445972?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06445972 being conducted?

This trial has 20 study locations across Arizona, California, Kentucky, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Esophageal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06445972's enrollment target sits among peer trials

210 33rd of 123 higher than 91 of 123 other Esophageal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Esophageal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06445972

Source: ClinicalTrials.gov NCT06445972, the US trial registry maintained by the National Library of Medicine. NCT06445972 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.