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RecruitingPhase 1 / Phase 2

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)

MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ifinatamab deruxtecan (I-DXd), alone or with other treatments, for prostate cancer that has spread and keeps growing despite treatment to lower testosterone. It checks how well treatment works, its safety, and a safe dose to use with other treatments. It also tracks PSA, a protein made by the prostate, during treatment.

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. * A safe dose level of I-DXd that can be used with other treatments. * Participant levels of prostate specific antigen (PSA) during treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests of tissue or cells show prostate adenocarcinoma, a type of prostate cancer, with no small cell cancer.
  • Cancer worsened within 6 months before screening while on treatment to lower testosterone or after surgery to remove both testicles.
  • Cancer has spread to distant parts of the body.
  • Had 1 or 2 androgen receptor pathway inhibitors, medicines that block male hormone signals, and cancer worsened during or after treatment.
  • If taking medicine to slow bone breakdown, the dose has been stable for at least 4 weeks before study group assignment.
  • Can do all usual activities or have limits only with hard physical activity, checked within 10 days before study group assignment.
  • Previously received a PARP inhibitor, a cancer medicine, if called for under local treatment approvals, or the study doctor judged it unsuitable.

Who can't join

  • Current, past, or suspected lung tissue inflammation called ILD or pneumonitis, or severe breathing problems from other lung illnesses. Past radiation-related pneumonitis is allowed if it did not need steroids.
  • Uncontrolled or serious heart or blood vessel disease.
  • Past pituitary gland problems, poorly controlled diabetes, or past or current adrenal gland failure, such as Addison’s disease.
  • Previously received taxane chemotherapy for prostate cancer that had spread and resisted treatment to lower testosterone.
  • Long-term steroids above the equivalent of 10 mg prednisone daily; exceptions include low-dose inhaled steroids, skin steroids for mild problems, and joint injections. Also excluded: radiation within 2 weeks before study treatment, or radiation side effects needing steroids.
  • Another cancer that is growing or needed treatment in the past 3 years, or known active cancer spread to the brain, spinal cord, or their lining.
  • An autoimmune disease, where the immune system attacks the body, that needed treatment acting throughout the body in the past 2 years.
  • A past transplant of tissue or a solid organ from another person.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: The main inclusion criteria 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 distant 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 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current ILD, clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * 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 intra-articular steroid injections * 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

Study sites (9)

CA

DC

MI

NY

PA

TN

WA