NCT07908524Toborzás még nem indult1/2. fázis
MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 2.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 290 (tervezett)
- Első benyújtás
- 2026. okt. 26.
- Kezdés
- 2026. dec. 14.
- Elsődleges befejezés
- 2032. jún. 29.
- Fő szponzor
- Merck Sharp & Dohme LLC
- Betegségek
- Prosztatarák
- NCT-szám
- NCT07908524
- EU CT-szám
- 2026-526240-13-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 290
- 2026. dec. 14. és az elsődleges befejezés (2032. jún. 29.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- 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
Más betegség
- 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
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- 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
Egyéb
- The main exclusion criteria include but are not limited to the following:
- Is unable to swallow tablets/capsules
- Has had a "superscan" bone scan
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: csak férfiak · Egészséges önkénteseket nem fogad
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