> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-of-ifinatamab-deruxtecan-based-treatment-99be48a0-44f7-46eb-bdf5-d3d2adc6018e > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) Participants 360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) Start date 2025-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) Number of sites 82 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Short 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Dates **Completion date** 2031-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **First posted** 2025-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Primary completion date** 2031-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Start date** 2025-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Size and sites **Participants** 360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Planned participants** 360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Number of sites** 82 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Identifiers **Registry ID** NCT06863272 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **ClinicalTrials.gov ID** NCT06863272 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Outcomes ### Primary outcomes 1. Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only Timeframe: Up to approximately 21 days The following events if considered drug related by the Investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not based on laboratory value); Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with clinically significant bleeding; Nonhematologic AEs ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for \\>1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 or 4 febrile neutropenia; Study intervention - related toxicities that lead to discontinuation of study treatment during Cycle 1; Prolonged delay (\\>2 weeks) in initiating Cycles 2 due to treatment-related toxicity; Missing \\>25% of study intervention doses as a result of treatment-related AE during Cycle 1; Grade 5 toxicity. 2. Efficacy Phase: Number of Participants Who Experienced an Adverse Event (AE) Timeframe: Up to approximately 54 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. 3. Efficacy Phase: Number of Participants Who Discontinued Study Intervention Due to an AE Timeframe: Up to approximately 24 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. 4. Efficacy Phase: Prostate-Specific Antigen (PSA) response rate Timeframe: Up to approximately 54 months PSA response is defined per prostate cancer working group (PCWG) criteria as a reduction in the PSA level of 50% or more from baseline measured at consecutive assessments at least 3 weeks apart. 5. Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only Timeframe: Up to approximately 21 days The following events if considered drug related by the Investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not based on laboratory value); Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with clinically significant bleeding; Nonhematologic AEs ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for \\>1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 or 4 febrile neutropenia; Study intervention - related toxicities that lead to discontinuation of study treatment during Cycle 1; Prolonged delay (\\>2 weeks) in initiating Cycles 2 due to treatment-related toxicity; Missing \\>25% of study intervention doses as a result of treatment-related AE during Cycle 1; Grade 5 toxicity. 6. Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE) - Combination Arms Only Timeframe: Up to approximately 21 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. 7. Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE - Combination Arms Only Timeframe: Up to approximately 21 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. ### Secondary outcomes 1. Objective Response Rate (ORR) Timeframe: Up to approximately 54 months ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per PCWG3-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. 2. Radiographic Progression-Free Survival (rPFS) Timeframe: Up to approximately 54 months rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG3-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG3-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG3-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (\\>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG3 rules include new bone lesions. The rPFS per PCWG3-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method will be used to estimate the rPFS curve in each treatment arm 3. Overall Survival (OS) Timeframe: Up to approximately 54 months Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method will be used to estimate the survival curves. 4. Duration of Response (DOR) Timeframe: Up to approximately 54 months DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per PCWG3-modified RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥ 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented. The nonparametric Kaplan-Meier method will be used to estimate the DOR in each treatment arm. 5. Time from allocation/randomization to initiation of the first subsequent anticancer therapy (TFST) Timeframe: Up to approximately 54 months TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first. The nonparametric Kaplan-Meier method will be used to estimate the TFST in each treatment arm. 6. Time to Prostate-Specific Antigen (PSA) Progression Timeframe: Up to approximately 54 months Time to PSA progression is defined as the time from randomization to PSA progression. Participants without PSA progression will be censored at the last PSA assessment date. The PSA progression date is defined as the date of: 1\\) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, OR 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. 7. Time to pain progression (TTPP) Timeframe: Up to approximately 54 months The time from allocation/randomization to pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 "worst pain in 24 hours" and by the Analgesic Quantification Algorithm (AQA) score. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Sites - UCLA Hematology & Oncology ( Site 0003)Los Angeles, United StatesRecruiting - University of California-Irvine Medical Center ( Site 0016)Orange, United StatesRecruiting - UCSF Medical Center at Mission Bay ( Site 0034)San Francisco, United StatesRecruiting - MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)Washington D.C., United StatesRecruiting - University of Michigan ( Site 0021)Ann Arbor, United StatesRecruiting - Memorial Sloan Kettering Cancer Center ( Site 0006)New York, United StatesRecruiting - UPMC Hillman Cancer Center ( Site 0014)Pittsburgh, United StatesRecruiting - The West Clinic, PLLC dba West Cancer Center ( Site 0005)Germantown, United StatesRecruiting - Fred Hutchinson Cancer Center ( Site 0013)Seattle, United StatesRecruiting - Instituto Alexander Fleming ( Site 0202)Ciudad Autónoma de Buenos Aires, ArgentinaRecruiting - Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)La Rioja, ArgentinaRecruiting - Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)Macquarie University, AustraliaRecruiting - Liga Norte Riograndense Contra o Câncer ( Site 0271)Natal, BrazilRecruiting - Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)Porto Alegre, BrazilRecruiting - Hospital Moinhos de Vento ( Site 0278)Porto Alegre, BrazilRecruiting - Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)Bragança Paulista, BrazilRecruiting - Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273)Ribeirão Preto, BrazilRecruiting - Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263)São José do Rio Preto, BrazilRecruiting - Hospital Alemao Oswaldo Cruz ( Site 0279)São Paulo, BrazilRecruiting - IPITEC ( Site 0275)São Paulo, BrazilRecruiting - IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)São Paulo, BrazilRecruiting - BC Cancer - Vancouver Center ( Site 0103)Vancouver, CanadaRecruiting - Sunnybrook Research Institute ( Site 0109)Toronto, CanadaRecruiting - Princess Margaret Cancer Centre ( Site 0102)Toronto, CanadaRecruiting - Jewish General Hospital ( Site 0108)Montreal, CanadaRecruiting And 57 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](http://www.merckclinicaltrials.com/) ### Other registry identifiers (3) - MK-2400-01A - U1111-1310-5406 - 2024-516036-94-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06863272) ## Related records ### Drugs (6) - [Abiraterone acetate](https://trialight.com/data/asset/abiraterone-acetate-2c6662c6-31e9-49ed-a022-f76f326fbd3e.md) - [Cetirizine hydrochloride](https://trialight.com/data/asset/cetirizine-hydrochloride-0f5b8ec9-315b-492f-b7a3-de74652b5fd2.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Enzalutamide](https://trialight.com/data/asset/enzalutamide-d1214ac0-68e5-4752-9999-977e028ec483.md) - [Ifinatamab deruxtecan](https://trialight.com/data/asset/ifinatamab-deruxtecan-31d740bc-d158-4964-a2dd-567df38e9e3d.md) - [Opevesostat](https://trialight.com/data/asset/opevesostat-e2e44731-5c22-4113-8383-ea545425e9df.md) ### Collaborators (1) - [Daiichi Sankyo](https://trialight.com/data/company/daiichi-sankyo-3b5789c1-b2e3-4a47-8ee5-e5e8854d8958.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Targets (18) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) - [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) - [HRH1](https://trialight.com/data/target/hrh1-066d4575-4b1c-5ce9-adf8-b080f76b770b.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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