Colorectal CancerPhase 1/2NCT06428409
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
A Phase 1/2 study testing Sacituzumab tirumotecan, Fluorouracil (5-FU) and Leucovorin (LV) or levoleucovorin in people with Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, run by Merck Sharp & Dohme LLC at 55 sites in 13 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer
- What is being tested?
- Sacituzumab tirumotecan, Fluorouracil (5-FU) and Leucovorin (LV) or levoleucovorin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 55 sitesin 13 countries
- Study dates
- 20 Jun 2024to 16 Oct 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has one of the following cancers:
- Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer
- Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer
- Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer
- Advanced and/or unresectable BTC and has not received prior therapy for the cancer
- For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History of severe eye disease
- For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
Trial locations and contacts
55 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
55 sites in 13 countries
United States13 sites, 11 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus ( Site 0299)
Aurora, Colorado, 80045
Study Coordinator, 303-724-8644
- Recruiting
University of Colorado Anschutz Medical Campus ( Site 0325)
Aurora, Colorado, 80045
Study Coordinator, 720-848-0300
- Recruiting
University of Colorado Anschutz Medical Campus ( Site 0326)
Aurora, Colorado, 80045
Study Coordinator, 720-848-0300
- Recruiting
University of Florida College of Medicine ( Site 0281)
Gainesville, Florida, 32610
Study Coordinator, 352-265-5121
- Recruiting
University of Texas MD Anderson Cancer Center ( Site 0316)
Houston, Texas, 77030
Study Coordinator, 713-792-2828
- Recruiting
UCLA ( Site 0317)
Los Angeles, California, 90095
Study Coordinator, 310-633-8400
- Recruiting
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
Madison, Wisconsin, 53792
Study Coordinator, 800-622-8922
- Completed
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
Marietta, Georgia, 30060
- Active, not recruiting
Mount Sinai Cancer Center ( Site 0287)
Miami Beach, Florida, 33140
- Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
Mineola, New York, 11501
Study Coordinator, 646-599-4083
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
New York, New York, 10016
Study Coordinator, 212-731-6000
- Recruiting
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
Roanoke, Virginia, 24014
Study Coordinator, 540-491-2240
- Recruiting
Sibley Memorial Hospital ( Site 0310)
Washington D.C., District of Columbia, 20016
Study Coordinator, 202-660-6500
China6 sites, 3 recruiting
- Recruiting
Beijing Cancer hospital-Digestive Oncology ( Site 0061)
Beijing, Beijing Municipality, 100142
Study Coordinator, 010-88196340
- Active, not recruiting
Hunan Cancer Hospital-intervention department ( Site 0066)
Changsha, Hunan, 410013
- Recruiting
West China Hospital, Sichuan University ( Site 0068)
Chengdu, Sichuan, 610041
Study Coordinator, 028-85423203
- Recruiting
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
Fuzhou, Fujian, 350025
Study Coordinator, 0591-22859663
- Active, not recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
Shanghai, Shanghai Municipality, 200127
- Active, not recruiting
Wuhan Union Hospital Cancer Center. ( Site 0064)
Wuhan, Hubei, 430024
Australia5 sites
- Active, not recruiting
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
Brisbane, Queensland, 4029
- Active, not recruiting
Epworth Freemasons ( Site 0005)
East Melbourne, Victoria, 3002
- Active, not recruiting
Frankston Hospital-Oncology and Haematology ( Site 0004)
Frankston, Victoria, 3199
- Active, not recruiting
One Clinical Research ( Site 0002)
Nedlands, Western Australia, 6009
- Active, not recruiting
Westmead Hospital ( Site 0003)
Westmead, New South Wales, 2145
Taiwan5 sites
- Active, not recruiting
China Medical University Hospital ( Site 0223)
Taichung, 404332
- Active, not recruiting
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
Tainan, 704
- Active, not recruiting
National Taiwan University Hospital-Oncology ( Site 0225)
Taipei, 10002
- Active, not recruiting
Taipei Veterans General Hospital ( Site 0221)
Taipei, 112
- Active, not recruiting
Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
Taoyuan, 33305
Chile4 sites, 4 recruiting
- Recruiting
FALP-UIDO ( Site 0041)
Providencia, Region M. de Santiago, 7500921
Study Coordinator, +56228205798
- Recruiting
Clínica UC San Carlos de Apoquindo ( Site 0043)
Santiago, Region M. de Santiago, 7620002
Study Coordinator, +56227548924
- Recruiting
Bradfordhill-Clinical Area ( Site 0047)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, +56991291852
- Recruiting
James Lind Centro de Investigacion del Cancer ( Site 0048)
Temuco, Araucania, 4800827
Study Coordinator, +56452982404
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Hospital ( Site 0161)
Seoul, 03080
Study Coordinator, 82-2-2072-0701
- Recruiting
Severance Hospital, Yonsei University Health System ( Site 0164)
Seoul, 03722
Study Coordinator, 82-2-2228-8137
- Recruiting
Asan Medical Center ( Site 0163)
Seoul, 05505
Study Coordinator, +82 2 3010 3945
- Recruiting
Samsung Medical Center ( Site 0162)
Seoul, 06351
Study Coordinator, +82234103549
Canada3 sites, 2 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
Montreal, Quebec, H2X 0A9
Study Coordinator, 5148908000
- Active, not recruiting
McGill University Health Centre ( Site 0023)
Montreal, Quebec, H4A 3J1
- Recruiting
The Ottawa Hospital Cancer Centre ( Site 0027)
Ottawa, Ontario, K1H 8L6
Study Coordinator, 613-737-7700 x70185
Italy3 sites, 3 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
Milan, Lombardy, 20133
Study Coordinator, 390223903807
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
Milan, Lombardy, 20162
Study Coordinator, 390264442291
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
Roma, 00168
Study Coordinator, 390458128116
Spain3 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
Barcelona, 08035
Study Coordinator, +34 93 274 60 60
- Recruiting
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
Madrid, Madrid, Comunidad de, 28009
Study Coordinator, 914269070
- Active, not recruiting
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
Oviedo, Principality of Asturias, 33011
United Kingdom3 sites, 3 recruiting
- Recruiting
University Hospital Coventry & Warwickshire ( Site 0266)
Coventry, CV2 2DX
Study Coordinator, 02476967485
- Recruiting
Barts Health NHS Trust ( Site 0263)
London, England, E1 1RD
Study Coordinator, 07918804584
- Recruiting
Royal Free Hospital ( Site 0262)
London, England, NW3 2QG
Study Coordinator, 02077940500 ext38682
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital East ( Site 0121)
Kashiwa, Chiba, 277-8577
Study Coordinator, +81-4-7133-1111
- Recruiting
Kanagawa Cancer Center ( Site 0122)
Yokohama, Kanagawa, 241-8515
Study Coordinator, +81-45-520-2222
Switzerland2 sites, 2 recruiting
- Recruiting
Ospedale Regionale Bellinzona e Valli ( Site 0201)
Bellinzona, Canton Ticino, 6500
Study Coordinator, +41918119039
- Recruiting
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
Geneva, Canton of Geneva, 1211
Study Coordinator, +41223729862
Turkey (Türkiye)2 sites
- Completed
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)
Ankara, 06230
- Completed
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)
Ankara, 06800
About this study
Official title: A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers
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
- Being tested
- Sacituzumab tirumotecan, Fluorouracil (5-FU), Leucovorin (LV) or levoleucovorin, Rescue medication, Supportive care measures
- Medical subject headings
- Colorectal Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecanBiological
Also called MK-2870, SKB264
Given by IV infusion.
Fluorouracil (5-FU)Drug
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
Leucovorin (LV) or levoleucovorinDrug
LV or levoleucovorin is administered by IV infusion every 2 weeks.
Rescue medicationDrug
Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
Supportive care measuresDrug
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 and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
CisplatinDrug
Also called PLATINOL®
Given by IV infusion.
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®
Given by IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab tirumotecan + Chemotherapy | Experimental | Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. Receives: Biological: Sacituzumab tirumotecan; Drug: Fluorouracil (5-FU); Drug: Leucovorin (LV) or levoleucovorin; Drug: Rescue medication; Drug: Supportive care measures |
| Sacituzumab tirumotecan | Experimental | Participants will receive sacituzumab tirumotecan in one of two dose levels every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Supportive care measures |
| Sacituzumab tirumotecan + Cisplatin + Pembrolizumab | Experimental | Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years. Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Supportive care measures; Drug: Cisplatin; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
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.
Measured: Up to approximately 4 weeks
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
Measured: Up to approximately 63 months
Number of Participants who Discontinue Study Treatment due to an AE
An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
Measured: Up to approximately 63 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Measured: Up to approximately 63 months
Secondary outcomes (3)
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Measured: Up to approximately 63 months
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Measured: Up to approximately 63 months
Overall Survival (OS)
OS is the length of time from when the participant starts treatment until death from any cause
Measured: Up to approximately 63 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start20 Jun 2024
- Primary completion16 Oct 2029 (estimated)
- Study completion16 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428409
- Sponsor's protocol ID
- 9999-02A
- Other IDs
- MK-9999-02A, 2023-508703-21-00, U1111-1298-8273, jRCT2031240178, 2023
- Status last verified
- Oct 2026
- First submitted
- 20 May 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf