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Metastatic NeoplasmPhase 1NCT07030712

A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)

A Phase 1 study testing MK-8294 and CD8 PET Tracer in people with Metastatic Neoplasm, run by Merck Sharp & Dohme LLC at 8 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

MK-8294, the study medicine, is a type of targeted therapy designed to treat certain solid tumors. The main goals of this study are to learn about the safety of MK-8294 and if people can tolerate it and find the highest dose level of MK-8294 that people can tolerate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Neoplasm
What is being tested?
MK-8294 and CD8 PET Tracer
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
8 sitesin 3 countries
Study dates
23 Jul 2025to 1 Jul 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 histologically or cytologically confirmed advanced/metastatic solid tumor; including head and neck squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, breast cancer (triple negative breast cancer, Estrogen Receptor [ER]/progesterone receptor +, human epidermal growth factor receptor 2 negative [HER2-]), endometrial, and bladder cancer by pathology report and have previously failed standard treatment, lack standard treatment options, or are intolerant to standard treatment
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has a history of New York Heart Association Class II or greater heart failure
  • Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
  • Has ongoing radiation-related toxicities, requiring corticosteroids
  • Has known additional malignancy that is progressing or has required active treatment within the past 2 years
Show all 11Show fewer
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
  • Has active infection requiring systemic therapy
  • Has history of stem cell/solid organ transplant
  • Has not adequately recovered from major surgery or have ongoing surgical complications

Trial locations and contacts

8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

8 sites in 3 countries

United States4 sites, 4 recruiting

  • Northwestern University ( Site 0101)

    Chicago, Illinois, 60611

    Study Coordinator, 312-926-8105

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0105)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-5900

    Recruiting

  • Houston Methodist Hospital ( Site 0103)

    Houston, Texas, 77030

    Study Coordinator, 346-238-4516

    Recruiting

  • MD Anderson Cancer Center ( Site 0104)

    Houston, Texas, 77030

    Study Coordinator, 713-563-1930

    Recruiting

Other trials in United States

Israel2 sites, 2 recruiting

  • Rambam Health Care Campus ( Site 0201)

    Haifa, 3109601

    Study Coordinator, 972(47776234)

    Recruiting

  • Sheba Medical Center ( Site 0200)

    Ramat Gan, 5265601

    Study Coordinator, 972(35307039)

    Recruiting

Other trials in Israel

Netherlands2 sites, 2 recruiting

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300)

    Amsterdam, North Holland, 1066 CX

    Study Coordinator, +31205129111

    Recruiting

  • Radboudumc ( Site 0301)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, 0243611111

    Recruiting

Other trials in Netherlands

About this study

Official title: A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-8294 Monotherapy in Advanced Solid Tumors

MK-8294, the study medicine, is a type of targeted therapy designed to treat certain solid tumors. The main goals of this study are to learn about the safety of MK-8294 and if people can tolerate it and find the highest dose level of MK-8294 that people can tolerate.

Being tested
MK-8294, CD8 PET Tracer
Keywords
Metastases, Neoplasm
Medical subject headings
Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-8294Drug

    Also called DAB014236

    30 µg via intravenous (IV) infusion

  • MK-8294Drug

    Also called DAB014236

    100 µg via intravenous (IV) infusion

  • MK-8294Drug

    Also called DAB014236

    300 µg via intravenous (IV) infusion

  • MK-8294Drug

    Also called DAB014236

    1 mg via intravenous (IV) infusion

  • MK-8294Drug

    Also called DAB014236

    3 mg via intravenous (IV) infusion

  • MK-8294Drug

    Also called DAB014236

    10 mg via intravenous (IV) infusion

  • MK-8294Drug

    Also called DAB014236

    30 mg via intravenous (IV) infusion

  • MK-8294Drug

    Also called DAB014236

    70 mg via intravenous (IV) infusion

  • CD8 PET TracerOther

    Also called GEH200520 + GEH200521 (18F)

    IV Infusion

Study groups in NCT07030712
Study groupRoleWhat they receive
MK-8294ExperimentalParticipants will receive MK-8294 monotherapy in escalating doses starting from 30 µg up to a planned 70 mg via intravenous (IV) infusion. In addition, intermediate doses may also be assessed. MK-8294 will be administered on Day 1, Day 8, and Day 15 of each cycle (each cycle = 21 days). Per protocol treatment of MK-8294 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. Participants may also receive a cluster of differentiation 8 (CD8) positron emission tomography (PET) tracer as a part of optional PET imaging.
Receives: Drug: MK-8294; Other: CD8 PET Tracer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who experience one or more dose-limiting toxicities (DLTs)

    DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period (up to 35 days) that results in a change to a given dose or a delay in initiating the next treatment and reported as the number of participants experiencing a DLT.

    Measured: Up to approximately 35 days

  2. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 2 years

  3. Number of Participants Who Discontinue Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study/study treatment due to an AE will be reported.

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with 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 Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.

    Measured: Up to approximately 2 years

  2. Area Under the Plasma Concentration-Time Curve (AUC) of MK-8294

    Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Area Under the Concentration-Time Curve of MK-8294.

    Measured: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

  3. Minimum Concentration (Cmin) of MK-8294

    Cmin is defined as the lowest concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmin of MK-8294.

    Measured: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

  4. Maximum Plasma Concentration (Cmax) of MK-8294

    Cmax is defined as the peak concentration of MK-8294 after administration of MK-8294. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Cmax of MK-8294.

    Measured: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

  5. Time to Maximum Plasma Concentration (Tmax) of MK-8294

    Tmax is defined as the time to reach Cmax. Blood samples collected pre-dose and at multiple timepoints post-dose will be used for the determination of Tmax of MK-8294.

    Measured: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

  6. Incidence of Antidrug Antibodies (ADA) to MK-8294

    Blood samples will be collected pre-dose and at designated time points to determine the ADA response to MK-8294. The incidence of ADAs over time will be presented.

    Measured: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

  7. Titer of ADA to MK-8294

    Blood samples will be collected pre-dose and at designated time points to determine the ADA titers to MK-8294.

    Measured: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study start23 Jul 2025
  3. Primary completion1 Jul 2029 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030712
Sponsor's protocol ID
8294-001
Other IDs
2024-516870-31-00, U1111-1311-2807, MK-8294-001
Status last verified
Oct 2026
First submitted
12 Jun 2025
Last updated
13 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-8294 and CD8 PET Tracer in people with Metastatic Neoplasm, run by Merck Sharp & Dohme LLC at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Israel, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who experience one or more dose-limiting toxicities (DLTs) (time frame: Up to approximately 35 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07030712.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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