Actively Recruiting
Phase 12 Study of Ifinatamab Deruxtecan Alone or with Other Treatments for Metastatic Castration-Resistant Prostate Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-29
360
Participants Needed
80
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan I-DXd, alone or combined with other treatments, for people with metastatic castration-resistant prostate cancer mCRPC. This study aims to find a safe dose of I-DXd in combination with other therapies and to monitor prostate specific antigen PSA levels during treatment. It is a phase 12, open-label study under the MK-2400-U01 master protocol. Participants may receive one of several treatments docetaxel given intravenously every three weeks for up to 10 cycles I-DXd alone administered intravenously every three weeks until side effects, disease progression, death, or withdrawal I-DXd combined with MK-5684 taken orally or I-DXd combined with an androgen receptor pathway inhibitor either abiraterone acetate or enzalutamide taken orally. The study includes a dose escalation phase followed by longer treatment periods. During the study, participants will be monitored for treatment side effects, PSA response, and other outcomes such as disease progression and survival over several years. Researchers will track adverse events, dose-limiting toxicities, and reasons for stopping treatment. The total follow-up may last up to about 54 months, with regular assessments including safety, efficacy, and quality of life measures.
CONDITIONS
Brief 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- Evidence of metastatic prostate cancer progression during androgen deprivation therapy within 6 months before screening
- Current metastatic disease
- Prior treatment with 1 or 2 androgen receptor pathway inhibitors with progression during or after treatment
- Stable bone resorptive therapy for 4 or more weeks before randomization if applicable
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization
- Prior treatment with poly-ADP-ribose polymerase inhibitors if indicated or ineligible for such treatment
You will not qualify if you...
- History of interstitial lung disease or pneumonitis requiring steroids, or current or suspected ILD/pneumonitis
- Severe pulmonary compromise from other lung illnesses
- Uncontrolled or significant cardiovascular disease
- History of pituitary dysfunction
- Poorly controlled diabetes mellitus
- History or current adrenal insufficiency (e.g., Addison's disease)
- Prior treatment with taxane-based chemotherapy for mCRPC
- Chronic steroid use over 10 mg daily prednisone equivalent except for certain inhaled or topical steroids
- Radiotherapy within 2 weeks before study start or radiation-related toxicities requiring corticosteroids
- Active malignancy requiring treatment within past 3 years
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of allogeneic tissue or solid organ transplant
Research Team
T
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