Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06428409 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
A Phase 1 study of Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT06428409: Recruiting Phase 1 study of Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by Merck Sharp & Dohme.
NCT06428409 is a Phase 1 study of Colorectal Cancer and Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 220 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06428409, a Phase 1 study of Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn: * About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it * How many people have the cancer respond (get smaller or go away) to treatment
Primary Outcome
A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported.
Conditions Studied
Interventions
- BIOLOGICAL Sacituzumab tirumotecan
- DRUG Supportive care measures
- DRUG Fluorouracil (5-FU)
- DRUG Leucovorin (LV) or levoleucovorin
- DRUG Rescue medication
Study Locations (20)
Colorado
- University of Colorado Anschutz Medical Campus ( Site 0299) - Aurora
- University of Colorado Anschutz Medical Campus ( Site 0325) - Aurora
- University of Colorado Anschutz Medical Campus ( Site 0326) - Aurora
Florida
- University of Florida College of Medicine ( Site 0281) - Gainesville
- Mount Sinai Cancer Center ( Site 0287) - Miami Beach
New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327) - Mineola
- Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324) - New York
Victoria
- Epworth Freemasons ( Site 0005) - East Melbourne
- Frankston Hospital-Oncology and Haematology ( Site 0004) - Frankston
California
- UCLA ( Site 0317) - Los Angeles
District of Columbia
- Sibley Memorial Hospital ( Site 0310) - Washington D.C.
Georgia
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303) - Marietta
Texas
- University of Texas MD Anderson Cancer Center ( Site 0316) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2024-06-20 |
| Est. Completion | 2029-10-16 |
| Phase | Phase 1 |
What NCT06428409 shows while recruiting
NCT06428409 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Sacituzumab tirumotecan is the first listed.
NCT06428409 names 20 study sites across 15 states, led by Colorado, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT06428409 about?
NCT06428409 is a clinical study titled "A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)". Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surge...
What is the current status of trial NCT06428409?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2024-06-20. Estimated completion is 2029-10-16.
What conditions does trial NCT06428409 study?
This clinical trial studies the following conditions: Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer.
What interventions are being tested in trial NCT06428409?
The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Supportive care measures (DRUG), Fluorouracil (5-FU) (DRUG), Leucovorin (LV) or levoleucovorin (DRUG), Rescue medication (DRUG).
Who is sponsoring clinical trial NCT06428409?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06428409 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal 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 NCT06428409's enrollment target sits among peer trials
220 139th of 381 higher than 241 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal 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
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
RECRUITING · Phase 1
-
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
RECRUITING · Phase 1
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00920972 · 220 participants · Phase 1
Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases
- NCT01851642 · 220 participants
Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs
- NCT02582021 · 220 participants
WISE CVD - Continuation (WISE HFpEF)
- NCT04067830 · 220 participants · Phase 2
Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI