Trial · NCT07908524
MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)
NCT07908524, Phase 1, Phase 2, Not yet recruiting, Merck Sharp & Dohme LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A). Trials, record NCT07908524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07908524
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)
- NCT number
- NCT07908524
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 290 participants, estimated
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Sacituzumab tirumotecan, Rescue medication, Docetaxel, Prednisone, Opevesostat, Abiraterone acetate, Enzalutamide, Prednisolone, Fludrocortisone, Dexamethasone
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy Phase: Objective Response Rate (ORR) | Up to approximately 66 months | 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. |
| Primary | Efficacy Phase: Number of Participants Who Experience at Least One Adverse Event (AE) | Up to approximately 66 months | 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. |
| Primary | Efficacy Phase: Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 66 months | 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. |
| Primary | Safety Lead-In (Combination Arms Only): Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) | Up to approximately 28 days | 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. |
| Primary | Safety Lead-In (Combination Arms Only): Number of Participants Who Experience at Least One AE | Up to approximately 66 months | 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. |
| Primary | Safety Lead-In (Combination Arms Only): Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 66 months | 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. |
| Secondary | Efficacy Phase: Prostate-Specific Antigen (PSA) Response Rate | Up to approximately 66 months | 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. |
| Secondary | Efficacy Phase: Radiographic Progression-Free Survival (rPFS) | Up to approximately 66 months | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07908524
GET https://conductscience.org/api/trials/v1/NCT07908524/registered