Raludotatug Deruxtecan for Ovarian Cancer

Recruiting at 15 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Steroids, Cadherin-6 agents

Disqualifiers: Cardiovascular disease, Pulmonary compromise, CNS metastases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 months for combination with carboplatin or paclitaxel; until disease progression for combination with bevacizumab

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for individuals with relapsed high-grade serous ovarian cancer, where the cancer returns after treatment and grows rapidly. Researchers are testing Raludotatug Deruxtecan, a drug that targets and destroys cancer cells, in combination with other cancer treatments. The aim is to determine if this combination is safe and effective in shrinking or eliminating the cancer. This trial may suit those whose cancer has returned and spread quickly, especially if previous treatments were short-lived. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received prior systemic anticancer therapy within 4 weeks before starting the study treatment.

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

Previous studies have shown that raludotatug deruxtecan (R-DXd) is safe for people with ovarian cancer. Research indicates that patients tolerated R-DXd well, with manageable side effects. In one study, about half of the patients experienced tumor shrinkage, suggesting the treatment's effectiveness while maintaining safety.

In this trial, R-DXd is combined with other treatments such as paclitaxel, carboplatin, bevacizumab, and pembrolizumab. The goal is to assess how well patients tolerate these combinations. While each drug is known to be safe individually, the trial aims to confirm their safety when used with R-DXd.

As this trial is in its early stages, the primary focus is on ensuring the treatment's safety for participants. So far, evidence supports that R-DXd can be safely administered, especially considering previous patient responses. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Raludotatug deruxtecan is unique because it combines a powerful antibody-drug conjugate with various cancer-fighting agents, aiming for a more targeted approach against ovarian cancer. Unlike traditional treatments like carboplatin or paclitaxel that broadly attack cells, raludotatug deruxtecan specifically targets cancer cells by delivering a cytotoxic payload directly to them, potentially reducing side effects and increasing effectiveness. Researchers are particularly excited about its flexibility in combination with other agents like bevacizumab and pembrolizumab, which might enhance its ability to overcome both platinum-resistant and platinum-sensitive ovarian cancer. This tailored mechanism of action represents a promising advancement over current options, which typically involve more generalized chemotherapy.

What evidence suggests that this trial's treatments could be effective for relapsed high-grade serous ovarian cancer?

Research shows that raludotatug deruxtecan (R-DXd) offers promising results for treating relapsed high-grade serous ovarian cancer. Studies found that about 50.5% of patients experienced tumor reduction or disappearance, with results appearing on average in about 7.1 weeks. This trial will explore various combinations of R-DXd with other treatments, such as paclitaxel, bevacizumab, carboplatin, and pembrolizumab, to assess their effectiveness and manageability. While some patients experienced side effects, most managed them effectively. Overall, early evidence suggests that R-DXd could be a strong option against this aggressive cancer type. ^{1 2 3 4 6}

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 people with high-grade serous ovarian cancer that has returned after treatment. Participants must have had 1-3 prior treatments, show measurable disease progression, and be fit enough for chemotherapy. They should not have been heavily pre-treated or have conditions that exclude them from receiving bevacizumab.

Inclusion Criteria

My cancer can be measured by scans.

I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.

I had hepatitis C but my current tests show no virus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of raludotatug deruxtecan in combination with other agents until disease progression or discontinuation

Up to 4 months for combination with carboplatin or paclitaxel; until disease progression for combination with bevacizumab

Dose-limiting Toxicity Evaluation

Participants are monitored for dose-limiting toxicities to assess safety of the treatment

Up to 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Raludotatug Deruxtecan

Trial Overview

The study tests Raludotatug Deruxtecan (R-DXd), an antibody drug conjugate, combined with standard therapies like Carboplatin, Paclitaxel, and Bevacizumab. It aims to see if R-DXd is safe and tolerable when used alongside these established treatments.

How Is the Trial Designed?

Group I: Cohort D (R-DXd Phase 2 +/- Bevacizumab) Experimental Treatment 3 Interventions

Participants with platinum-sensitive recurrent ovarian cancer (PSROC) receive RP2D of IV raludotatug deruxtecan in combination with or without bevacizumab until disease progression or discontinuation.

Group II: Cohort C-1 (R-DXd + Pembrolizumab) Experimental Treatment 3 Interventions

Participants receive escalating doses of IV raludotatug deruxtecan in combination with pembrolizumab. Participants can receive up to a maximum of thirty-five 3-week cycles of pembrolizumab (approximately 2 years) and will receive raludotatug deruxtecan until disease progression or discontinuation.

Group III: Cohort B-2 (R-DXd Phase 2 + Bevacizumab) Experimental Treatment 3 Interventions

Participants with platinum-resistant recurrent ovarian cancer (PRROC) receive recommended Phase 2 dose (RP2D) of IV raludotatug deruxtecan in combination with bevacizumab until disease progression or discontinuation.

Group IV: Cohort B-1 (R-DXd + Bevacizumab) Experimental Treatment 3 Interventions

Participants receive escalating doses of IV raludotatug deruxtecan in combination with bevacizumab until disease progression or discontinuation.

Group V: Cohort A-1 Arm 3 (R-DXd + Carboplatin Dose 2) Experimental Treatment 3 Interventions

Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan in combination with carboplatin at Dose 2. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation.

Group VI: Cohort A-1 Arm 2 (R-DXd + Paclitaxel) Experimental Treatment 3 Interventions

Participants receive escalating doses of IV raludotatug deruxtecan in combination with paclitaxel. Participants can receive up to a maximum of six 3-week cycles of paclitaxel (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation.

Group VII: Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1) Experimental Treatment 3 Interventions

Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan in combination with carboplatin at Dose 1. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation.

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

Published Research Related to This Trial

In a phase II study involving 41 patients with ovarian cancer resistant to platinum and taxane treatments, the combination of docetaxel and irinotecan showed a low overall response rate of 6.3%, indicating limited efficacy for this patient group.

The treatment was generally well tolerated, with neutropenia being the most common severe side effect (56.1% of patients), but the combination did not significantly improve survival outcomes, with a median overall survival of only 45.3 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel/irinotecan combination chemotherapy in platinum/taxane-refractory and -resistant ovarian cancer: JGOG/WJGOG Intergroup Study. Ushijima, K., Kamura, T., Tamura, K., et al.[2021]

Citations

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merck.com

merck.com/news/raludotatug-deruxtecan-demonstrated-clinically-meaningful-response-rates-in-patients-with-recurrent-platinum-resistant-ovarian-primary-peritoneal-or-fallopian-tube-cancer-in-phase-2-part-of-rejoice-o/

Raludotatug Deruxtecan Demonstrated Clinically ...

October 19, 2025 8:46 am EDT. An objective response rate of 50.5% was observed with raludotatug deruxtecan across all dose levels in these ...

2.

onclive.com

onclive.com/view/raludotatug-deruxtecan-demonstrates-promising-efficacy-safety-in-platinum-resistant-ovarian-cancer

Raludotatug Deruxtecan Demonstrates Promising Efficacy, ...

R-DXd showed a 50.5% objective response rate in platinum-resistant ovarian cancer patients, with a median response time of 7.1 weeks. · The ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06161025

NCT06161025 | A Study of Raludotatug Deruxtecan (R- ...

This study will focus on R-DXd in participants with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer.

4.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534%2823%2902761-8/fulltext

745MO Raludotatug deruxtecan (R-DXd; DS-6000) ...

In an ongoing phase 1 trial (NCT04707248), R-DXd demonstrated an acceptable safety profile and an early efficacy signal.

5.

esmoopen.com

esmoopen.com/article/S2059-7029(25)01075-0/fulltext

77MO Raludotatug deruxtecan (R-DXd) monotherapy in ...

Treatment-emergent treatment-related adverse events (AEs) were reported in 16 pts (88.9%; Grade ≥3 in 9 pts [50.0%]) and led to R-DXd discontinuation in 2 pts ( ...

6.

daiichisankyo.us

daiichisankyo.us/press-releases/-/article/raludotatug-deruxtecan-continues-to-demonstrate-promising-clinical-activity-in-patients-with-advanced-ovarian-cancer-in-early-trial

Raludotatug Deruxtecan Continues to Demonstrate ...

The phase 1 trial is the first-in-human, open-label study evaluating the safety and efficacy of raludotatug deruxtecan in patients with advanced ...