MK-2870-01A Substudy: A Phase I/II, 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)

Study Identifier:
MK-2870-01A
CT.gov Identifier:
NCT07908524
EudraCT Identifier:
202652624013
EU Trial (CTIS) Number:
2026-526240-13-00
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study 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.

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.

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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Prostate
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Male
Age
18+ years
Study Drug
Drug: Docetaxel: Participants will receive docetaxel every 3 weeks by intravenous (IV) infusion. Participants will also receive either prednisone or prednisolone daily (or per approved product label). Sac-TMT (Dose 1): Participants will receive sac-TMT monotherapy every 2 weeks (q2w) by IV infusion. Sac-TMT (Dose 2): Participants will receive sac-TMT monotherapy q2w by IV infusion. Sac-TMT Plus Opevesostat: Participants 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. Sac-TMT Plus Androgen Receptor Pathway Inhibitor (ARPI): Abiraterone Acetate or Enzalutamide: Participants 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).
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • Inclusion Criteria:
  • 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
Exclusion criteria
  • Exclusion Criteria:
  • 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
  • * 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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Will Be Recruiting
Condition(s) Treated at Site
Prostate