NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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)
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)

NCT06863272

RecruitingPhase 1, Phase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Castration-Resistant Prostatic Cancer, Metastasis

Interventions: Docetaxel, Ifinatamab Deruxtecan, Opevesostat, Abiraterone, Enzalutamide

Countries: United States, Argentina, Australia, Brazil, Canada, Chile, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (82)
  • 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
  • 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
  • São Paulo, Brazil
  • Vancouver, British Columbia, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Sherbrooke, Quebec, Canada
  • Talca, Maule Region, Chile
  • Santiago, Region M. de Santiago, Chile
  • Santiago, Region M. de Santiago, Chile
  • Santiago, Region M. de Santiago, Chile
  • + 52 more on CT.gov