Ifinatamab Deruxtecan for Prostate Cancer

Recruiting at 220 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Androgen deprivation

Must not be taking: Taxane chemotherapy

Disqualifiers: Interstitial lung disease, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 36 months

1440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ifinatamab deruxtecan (I-DXd) for prostate cancer that has spread and is unresponsive to standard hormone therapy. Researchers aim to determine if I-DXd extends life and slows cancer growth compared to chemotherapy. The trial compares I-DXd to a commonly used chemotherapy drug, docetaxel, combined with prednisone. Participants should have prostate cancer that has progressed despite hormone therapy and previous treatment with one or two specific other medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in prostate cancer treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ifinatamab deruxtecan (I-DXd) is generally safe. In previous studies, patients who took I-DXd experienced manageable side effects. These patients had already tried other treatments before using I-DXd, yet they generally tolerated the treatment well.

This suggests that I-DXd could be safe for people with advanced prostate cancer, but further research is necessary to confirm this. For those considering joining a trial, it's important to know that this treatment has been tested in humans before, with manageable side effects. However, since experiences can vary, consulting a doctor is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Ifinatamab Deruxtecan is unique because it's an antibody-drug conjugate specifically designed to target and deliver chemotherapy directly to prostate cancer cells, potentially reducing the impact on healthy cells. Unlike standard treatments like docetaxel, which broadly attack cancer cells, Ifinatamab Deruxtecan combines a monoclonal antibody with a potent chemotherapy agent, aiming for higher precision and effectiveness. Researchers are excited about this approach because it could offer better outcomes with fewer side effects, marking a significant advancement in prostate cancer treatment.

What evidence suggests that ifinatamab deruxtecan might be an effective treatment for prostate cancer?

Research has shown that ifinatamab deruxtecan (I-DXd), which participants in this trial may receive, may help treat advanced prostate cancer that no longer responds to hormone therapy. In earlier studies, about 25% of patients with this cancer type experienced a positive response to I-DXd, with roughly one in four patients seeing their cancer shrink or stop growing. The treatment also had lasting effects, with benefits continuing for a significant time. These findings suggest that I-DXd might be an effective option for this type of prostate cancer. ^{1 2 3 4 5}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic castration-resistant prostate cancer (mCRPC) who have seen their cancer progress while on hormone therapy within the last 6 months. Participants must have previously been treated with 1 or 2 androgen receptor pathway inhibitors for at least 8 weeks.

Inclusion Criteria

I've had treatment with hormone blockers for at least 8 weeks and my cancer still grew.

I have advanced prostate cancer that is not responding to hormone therapy.

My prostate cancer got worse while on hormone therapy in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either I-DXd 12mg/kg every 3 weeks or docetaxel 75 mg/m^2 every 3 weeks with prednisone 10 mg/day

Up to approximately 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Ifinatamab Deruxtecan

Trial Overview The study compares a new medication, Ifinatamab Deruxtecan (I-DXd), against standard chemotherapy to see if I-DXd can help patients live longer overall and delay the growth or spread of cancer in those with mCRPC.

How Is the Trial Designed?

Group I: I-DXd Experimental Treatment 1 Intervention

Participants receive I-DXd 12mg/kg every 3 weeks (q3w)

Group II: Docetaxel Active Control 2 Interventions

Participants receive docetaxel 75 mg//m\^2 q3w and prednisone 10 mg/day or per approved product label

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Citations

1. urologytimes.com urologytimes.com/view/phase-3-trial-launches-of-ifinatamab-deruxtecan-vs-chemotherapy-in-mcrpc

Phase 3 trial launches of ifinatamab deruxtecan vs ... Data presented at the 2022 European Society of Medical Oncology (ESMO) Congress 3 showed a response rate of 33% (95% CI, 21 to 47) in this ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)01487-X/fulltext

PS3-3 Clinical and biomarker data from a phase 1/2 trial ... I-DXd showed a promising objective response rate (SCLC: 11/21 [52%]; ESCC: 6/28 [21%]; CRPC: 15/59 [25%]; sqNSCLC: 4/13 [31%]) and durable response (median ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06863272

NCT06863272 | A Clinical Study of Ifinatamab Deruxtecan ... 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 ...

4. daiichisankyo.com daiichisankyo.com/files/news/pressrelease/pdf/202508/20250818_E.pdf

"Ifinatamab Deruxtecan Granted Breakthrough Therapy ... The phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients ...

5. merck.com merck.com/news/ideate-prostate01-phase-3-trial-of-ifinatamab-deruxtecan-initiated-in-patients-with-pretreated-metastatic-castration-resistant-prostate-cancer/

IDeate-Prostate01 Phase 3 Trial of Ifinatamab Deruxtecan ... IDeate-Prostate01 is a multicenter, open-label, randomized phase 3 trial evaluating the safety and efficacy of ifinatamab deruxtecan (12 mg/kg) versus ...