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Metastatic Castration-resistant Prostate CancerPhase 1/2TroFuse-01ANCT07908524

MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)

A Phase 1/2 study testing Sacituzumab tirumotecan, Rescue medication and Docetaxel in people with Metastatic Castration-resistant Prostate Cancer, run by Merck Sharp & Dohme LLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer/androgen pathway modulator refractory (mCRPC/APMR). Current treatment for mCRPC includes chemotherapy, such as docetaxel. Chemotherapy is medicine that works to destroy cancer cells or stop them from growing. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Sacituzumab tirumotecan, Rescue medication and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
No sites listed yet
Study dates
14 Dec 2026to 29 Jun 2032
Phase
Phase 1/2
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • Have histologically or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
  • Have prostate cancer progression while on androgen deprivation therapy (ADT) or post-bilateral orchiectomy
  • Have received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for non-metastatic hormone-sensitive prostate cancer (nmHSPC)/androgen pathway modulation sensitive (APMS), metastatic hormone-sensitive prostate cancer (mHSPC)/APMS, non-metastatic castration-resistant prostate cancer (nmCRPC)/ androgen pathway modulation refractory (APMR), or metastatic castration-resistant prostate cancer (mCRPC)/APMR and progressed during or after at least 8 weeks of treatment (≥14 weeks of treatment for participants with bone progression)
  • Have had prior treatment with poly adenosine diphosphate ribose polymerase inhibitor (PARPi) if indicated by local approved regimen or were deemed ineligible to receive PARPi by the investigator
  • Participants with microsatellite instability (MSI)-high/deficient mismatch repair (dMMR) must have received programmed cell death 1 protein (PD-1) blocking antibody-based immunotherapy when indicated by local approved regimen, or be considered ineligible for PD-1-blocking antibody-based immunotherapy by the investigator

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Is unable to swallow tablets/capsules
  • Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has received prior treatment with taxane-based chemotherapy agent for mCRPC/APMR
  • Has received prior therapy with trophoblast cell surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC) or topoisomerase I inhibitor (TOP1i) payload ADC
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  • Has had a "superscan" bone scan
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease, or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening

About this study

Official title: MK-2870-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2870-U01 Master Protocol to Evaluate the Safety and Efficacy of Sacituzumab Tirumotecan (Sac-TMT; MK-2870) Alone or in Combination for the Treatment of Participants With Metastatic Castration-Resistant Prostate Cancer/Androgen Pathway Modulator Refractory (mCRPC/APMR)

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer/androgen pathway modulator refractory (mCRPC/APMR). Current treatment for mCRPC includes chemotherapy, such as docetaxel. Chemotherapy is medicine that works to destroy cancer cells or stop them from growing.

In this trial, researchers want to learn if giving sacituzumab tirumotecan (sac-TMT) alone or with other treatments can treat mCRPC. Sac-TMT is a trial medicine that is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. Opevesostat is another trial medicine designed to block the body from making steroid hormones that cause the cancer cells to grow.

Read more

The goals of this trial are to learn:

  • How many participants have the cancer respond (gets smaller or goes away) to the trial treatments
  • About the safety of the trial treatments and if participants tolerate the treatments. Tolerate means participants will receive the trial treatments unless they need to stop it due to health problems.
Read the detailed description

This is a substudy of the master protocol MK-2870-U01.

Being tested
Sacituzumab tirumotecan, Rescue medication, Docetaxel, Prednisone, Opevesostat

What participants receive

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

  • Sacituzumab tirumotecanBiological

    Also called sac-TMT, MK-2870, SKB264

    IV infusion

  • Rescue medicationDrug

    Participants receiving sac-TMT may be administered the following rescue medications according to the approved product: granulocyte colony-stimulating factor, histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).

  • DocetaxelDrug

    IV infusion

  • PrednisoneDrug

    Oral administration

  • OpevesostatDrug

    Also called MK-5684

    Oral administration

  • Abiraterone acetateDrug

    Oral administration

  • EnzalutamideDrug

    Oral administration

  • PrednisoloneDrug

    Oral administration

  • FludrocortisoneDrug

    Oral administration

  • DexamethasoneDrug

    Oral administration

Study groups in NCT07908524
Study groupRoleWhat they receive
DocetaxelActive comparatorParticipants will receive docetaxel every 3 weeks by intravenous (IV) infusion. Participants will also receive either prednisone or prednisolone daily (or per approved product label).
Receives: Drug: Docetaxel; Drug: Prednisone; Drug: Prednisolone
Sac-TMT (Dose 1)ExperimentalParticipants will receive sac-TMT monotherapy every 2 weeks (q2w) by IV infusion.
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medication
Sac-TMT (Dose 2)ExperimentalParticipants will receive sac-TMT monotherapy q2w by IV infusion.
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medication
Sac-TMT Plus OpevesostatExperimentalParticipants will receive sac-TMT q2w by IV infusion in combination with oral administration of opevesostat twice daily until any of the criterion for discontinuation are met. Participants receiving opevesostat will receive fludrocortisone and dexamethasone daily.
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Opevesostat; Drug: Fludrocortisone; Drug: Dexamethasone
Sac-TMT Plus Androgen Receptor Pathway Inhibitor (ARPI): Abiraterone Acetate or EnzalutamideExperimentalParticipants will receive sac-TMT q2w by IV infusion in combination with oral administration of an androgen receptor pathway inhibitor (ARPI), either abiraterone acetate daily or enzalutamide daily until any of the criterion for discontinuation are met. Participants receiving abiraterone acetate will also receive either prednisone or prednisolone daily (or per approved product label).
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Prednisone; Drug: Abiraterone acetate; Drug: Enzalutamide; Drug: Prednisolone

What is being measured

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

  1. Efficacy Phase: 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 Prostate Cancer Working Group 4 (PCWG4)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (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 66 months

  2. Efficacy Phase: Number of Participants Who Experience at Least One Adverse Event (AE)

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

    Measured: Up to approximately 66 months

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

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

    Measured: Up to approximately 66 months

  4. Safety Lead-In (Combination Arms Only): Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)

    DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 28 days after the first dose of study intervention or prior to the third dose, whichever occurs first) that results in a change to a given dose or a delay in initiating the next treatment. The number of participants who experience a DLT will be reported.

    Measured: Up to approximately 28 days

  5. Safety Lead-In (Combination Arms Only): Number of Participants Who Experience at Least One AE

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

    Measured: Up to approximately 66 months

  6. Safety Lead-In (Combination Arms Only): Number of Participants Who Discontinue Study Intervention Due to an AE

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

    Measured: Up to approximately 66 months

Secondary outcomes (2)

  1. Efficacy Phase: Prostate-Specific Antigen (PSA) Response Rate

    PSA response is defined as having a postbaseline PSA reduction of at least 50% from baseline with a consecutive confirmation assessment at least 3 weeks later. The percentage of participants with a PSA response will be reported.

    Measured: Up to approximately 66 months

  2. Efficacy Phase: Radiographic Progression-Free Survival (rPFS)

    rPFS is defined as the time from randomization/allocation (Safety Lead-in) to the first documented progressive disease (PD), as assessed by PCWG4-Modified RECIST 1.1, or death from any cause, whichever occurs first. PD is defined as an increase of at least 20% 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. rPFS as assessed by BICR will be presented.

    Measured: Up to approximately 66 months

Timeline

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

  1. First posted2 Nov 2026
  2. Study start14 Dec 2026 (estimated)
  3. Primary completion29 Jun 2032 (estimated)
  4. Study completion29 Jun 2032 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization is used during the Efficacy Phase to compare treatment regimens. Prior to randomization, certain combination treatment arms undergo a non-randomized Safety Lead-in Phase to evaluate dose-limiting toxicities, safety, and tolerability and to establish a recommended dose for expansion.
Masking
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07908524
Sponsor's protocol ID
2870-01A
Other IDs
U1111-1337-5858, 2026-526240-13-00
Acronym
TroFuse-01A
Status last verified
Oct 2026
First submitted
26 Oct 2026
Last updated
2 Nov 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 1/2 study testing Sacituzumab tirumotecan, Rescue medication and Docetaxel in people with Metastatic Castration-resistant Prostate Cancer, run by Merck Sharp & Dohme LLC.

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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Phase: Objective Response Rate (ORR) (time frame: Up to approximately 66 months). The study lists 6 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 NCT07908524.

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 2 Nov 2026.

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