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New treatment option for Castration-Resistant Prostatic Cancer
Official title A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)
ClinicalTrials.gov ID: NCT06863272
What this study is testing
What is Docetaxel?
Docetaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for castration-resistant prostatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: The safety of the study treatment and if people tolerate it.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main include but are not limited to the following:
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening
- Has current evidence of metastatic disease
- Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment
You likely can't join if
- The main exclusion criteria include but are not limited to the following:
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis or suspected...
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Uncontrolled or significant cardiovascular disease
- History of pituitary dysfunction
- Poorly controlled diabetes mellitus
See the full eligibility criteria
- The main include but are not limited to the following:
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening
- Has current evidence of metastatic disease
- Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment
- Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before allocation/randomization
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 10 days before allocation/randomization
- Has prior treatment with poly-ADP-ribose polymerase inhibitors (PARPi) if indicated by local approved regimen or were deemed ineligible to receive PARPi by the investigator
- The main exclusion criteria include but are not limited to the following:
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis or suspected ILD/pneumonitis
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Uncontrolled or significant cardiovascular disease
- History of pituitary dysfunction
- Poorly controlled diabetes mellitus
- History or current condition of adrenal insufficiency (eg, Addison's disease)
- Has received prior treatment with taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC).
- Chronic steroid treatment (dose of \>10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease), topical steroids (for mild skin conditions), or...
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- 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
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of allogeneic tissue/solid organ transplant
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Germantown, Tennessee, United States
- Seattle, Washington, United States
- Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- La Rioja, Argentina
- Macquarie University, New South Wales, Australia
- Natal, Rio Grande do Norte, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Bragança Paulista, São Paulo, Brazil
- Ribeirão Preto, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, Brazil
- Vancouver, British Columbia, Canada
+ 49 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Ann Arbor, Michigan, United States; New York, New York, United States and 63 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.