R-DXd for Ovarian Cancer

Recruiting at 150 trial locations

Overseen By Medical Director Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Daiichi Sankyo, Inc.

Must not be taking: Steroids, Anticonvulsants, Chloroquine

Disqualifiers: Brain metastases, Cardiovascular disease, ILD/pneumonitis, others

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

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

Compensation: Varies

Number of Visits: 3

Duration: Up to 18 months

710 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of R-DXd, a new treatment for ovarian, peritoneal, or fallopian tube cancer. R-DXd (Raludotatug Deruxtecan) is administered through an IV every three weeks at varying doses to identify the most effective one. The study also compares R-DXd to standard chemotherapy drugs selected by the investigator. Suitable candidates have high-grade serous or endometrioid ovarian cancer and have undergone 1-3 previous cancer treatments but continue to experience disease progression. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) before starting the study drug. This includes stopping systemic anticancer therapy, chloroquine/hydroxychloroquine, and other investigational drugs for a specified time before the trial begins. It's best to discuss your specific medications with the study team to understand how they might be affected.

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

Research has shown that Raludotatug Deruxtecan (R-DXd) has been generally safe in earlier studies. In a study involving patients with certain types of ovarian cancer, R-DXd proved effective, and the side effects were manageable. Specifically, an earlier trial found that patients tolerated the treatment well, with the most common issues being mild to moderate.

While more data is always helpful, the fact that R-DXd is being tested in late-stage trials suggests that earlier tests found it to be generally safe for humans. Prospective participants can find reassurance in knowing that the treatment has already undergone significant testing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Raludotatug Deruxtecan (R-DXd) is unique because it combines a targeted antibody with a potent chemotherapy agent, allowing it to directly deliver treatment to cancer cells while sparing healthy ones. This antibody-drug conjugate targets a specific protein often found on ovarian cancer cells, potentially offering a more precise treatment option compared to traditional chemotherapies like paclitaxel or gemcitabine. Researchers are excited about R-DXd because of its potential to improve outcomes with fewer side effects, which could be a game-changer for patients with ovarian cancer.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Previous studies have shown that Raludotatug Deruxtecan (R-DXd) holds promise for treating ovarian cancer. Research indicates that about 50.5% of patients with platinum-resistant ovarian cancer responded positively to the treatment, with tumors either shrinking or ceasing to grow. The response typically occurred in about 7.1 weeks. In this trial, participants will be randomized to receive different dosages of R-DXd or an investigator's choice of standard treatments. This evidence suggests that R-DXd could be an effective option for those with difficult-to-treat ovarian cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Are You a Good Fit for This Trial?

This trial is for adults with high-grade ovarian, primary peritoneal, or fallopian tube cancer that's resistant to platinum-based treatments. Participants must have a tumor suitable for biopsy and agree to provide tissue samples. They should have had prior therapy including bevacizumab unless unsuitable due to intolerance.

Inclusion Criteria

I am at least 18 years old or the legal adult age in my country.

Required baseline local laboratory data (within 7 days before start of study drug administration)

Sign and date the informed consent form prior to the start of any study-specific qualification procedures

Exclusion Criteria

Inadequate washout period before Cycle 1 Day 1

My ovarian cancer is of a specific type (clear cell, mucinous, sarcomatous, mixed, or low-grade).

I do not have active brain tumors, spinal cord compression, or cancer in the lining of my brain and spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive R-DXd or investigator's choice of chemotherapy every 3 weeks

Up to 18 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 40 months

What Are the Treatments Tested in This Trial?

Interventions

• Raludotatug Deruxtecan (R-DXd)

Trial Overview The study tests R-DXd's safety and effectiveness against other drugs like Gemcitabine, Paclitaxel, Topotecan, PLD in patients with certain types of cancer. It aims to see if R-DXd can help where standard treatments haven't worked well.

How Is the Trial Designed?

Group I: Part B: R-DXd RP3D Q3W Experimental Treatment 1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at the Recommended Phase 3 Dose (RP3D) every 3 weeks (Q3W).

Group II: Part A: R-DXd 6.4 mg/kg Q3W Experimental Treatment 1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

Group III: Part A: R-DXd 5.6 mg/kg Q3W Experimental Treatment 1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at a dose of 5.6 mg/kg every 3 weeks (Q3W).

Group IV: Part A: R-DXd 4.8mg/kg Q3W Experimental Treatment 1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at a dose of 4.8 mg/kg every 3 weeks (Q3W).

Group V: Part B: Investigator's Choice Active Control 4 Interventions

Participants will be randomized to receive intravenous treatment with investigator's choice of paclitaxel, pegylated liposomal doxorubicin (PLD), gemcitabine, or topotecan.

Who Is Running the Clinical Trial?

Daiichi Sankyo, Inc.

Lead Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Daiichi Sankyo

Lead 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

Merck Sharp & Dohme LLC

Industry 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

Published Research Related to This Trial

In a study of 36 patients with recurrent epithelial ovarian cancer, the combination of docetaxel (DTX) and oxaliplatin (OXA) resulted in an overall response rate of 55.6%, with 8.3% achieving complete responses and 47.2% showing partial responses.

The treatment was found to have a tolerable safety profile, with the main side effects being hematological toxicities and peripheral neuropathy, indicating that while effective, monitoring for these adverse effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic effect of docetaxel combined with oxaliplatin for treatment of recurrent epithelial ovarian cancer]. Wang, J., Han, N., Wang, HL., et al.[2018]

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]

Mirvetuximab soravtansine is a promising antibody-drug conjugate that targets folate receptor-α, showing favorable tolerability and encouraging efficacy, particularly in patients with platinum-resistant ovarian cancer.

Ongoing Phase III and Phase Ib/II trials are currently assessing its effectiveness as a monotherapy and in combination treatments, which will clarify its potential role in treating advanced ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer. Moore, KN., Martin, LP., O'Malley, DM., et al.[2019]

Citations

1. 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 ... A confirmed objective response rate (ORR) of 50.5% (95% confidence interval [CI]: 40.6-60.3) was observed in patients (n=107)with platinum- ...

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. 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.

4. 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. R-DXd is an ...

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS3158

REJOICE-PanTumor01: A phase 2 signal-seeking study of ... A phase 2 signal-seeking study of raludotatug deruxtecan (R-DXd) in patients with advanced or metastatic gynecologic or genitourinary tumors.