Raludotatug Deruxtecan for Cancer

Recruiting at 59 trial locations

Overseen By Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Daiichi Sankyo

Must not be taking: Corticosteroids, CDH6-targeted agents

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: 32 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called raludotatug deruxtecan (R-DXd) to evaluate its efficacy and safety for individuals with certain advanced cancers. It targets solid tumors expressing a protein called cadherin-6, including some gynecological cancers like endometrial and cervical cancer, as well as genitourinary cancers like bladder and kidney cancer. Suitable patients have cancers that have recurred or worsened after previous treatments. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking 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 raludotatug deruxtecan is likely to be safe for humans?

Research has shown that raludotatug deruxtecan (R-DXd) has been tested for safety in various cancers, including ovarian and endometrial cancers. In these studies, the treatment was generally well-tolerated, though some side effects occurred. About 91% of patients experienced treatment-related side effects, with around 27% experiencing more serious side effects (grade 3-4). Importantly, no treatment-related deaths were reported.

The safety of R-DXd is considered manageable and similar to other treatments in its category. While most patients experienced some side effects, they were not severe for the majority. This suggests that R-DXd is relatively safe, though, like any treatment, it carries some risks.

For those considering trial participation, these details can assist in making informed decisions. ^{1 2 3 4 5}

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

Researchers are excited about Raludotatug Deruxtecan (R-DXd) because it offers a novel approach to treating various types of cancer, including urothelial, cervical, endometrial, clear cell renal carcinoma (ccRCC), and non-high-grade serous ovarian cancer. Unlike traditional treatments like chemotherapy and immunotherapy, R-DXd is an antibody-drug conjugate that delivers a potent cytotoxic agent directly to cancer cells, minimizing damage to healthy cells. This targeted delivery method can potentially enhance effectiveness and reduce side effects compared to standard treatments. Additionally, R-DXd is administered intravenously every three weeks, offering a convenient dosing schedule for patients. These unique features make it a promising candidate in the fight against cancer.

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

Research has shown that raludotatug deruxtecan (R-DXd) may effectively treat several types of cancer. In this trial, participants with various cancers, such as ovarian, urothelial, cervical, endometrial, and clear cell renal carcinoma, will receive R-DXd. Specifically, studies have found that 50.5% of ovarian cancer patients experienced a reduction or disappearance of their cancer after treatment. This result is particularly promising for patients whose cancer did not respond to standard platinum-based therapies. Additionally, R-DXd has demonstrated activity against tumors expressing a protein called CDH6, indicating it targets specific proteins in these cancers. These early findings support further research into R-DXd as a potential treatment for various solid tumors. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors, including specific gynecological and genitourinary cancers. Participants must have tumors expressing a protein called CDH6. Key exclusions will include certain medical conditions and treatments that could interfere with the study.

Inclusion Criteria

Has at least 1 measurable lesion according to RECIST version 1.1 per investigator assessment.

My cancer has worsened after my last treatment.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I do not have an active, uncontrolled infection.

I have not been treated with CDH6-targeted drugs or specific chemotherapy linked to antibodies.

I am on a daily steroid dose of more than 10 mg, with certain exceptions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive R-DXd administered intravenously every 3 weeks (Q3W) for various cancer cohorts

32 months

Visits every 3 weeks for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Raludotatug Deruxtecan

Trial Overview The trial is testing Raludotatug deruxtecan (R-DXd), a drug aimed at treating various advanced solid tumors by targeting CDH6 expression. It's an observational study to see how well this drug works on its own in different types of cancer.

How Is the Trial Designed?

Group I: Urothelial Cancer Cohort Experimental Treatment 1 Intervention

Participants with urothelial cancer who will receive R-DXd administered intravenously Q3W.

Group II: Non-high-grade Serous Ovarian Cancer Experimental Treatment 1 Intervention

Participants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W.

Group III: Endometrial Cancer Cohort Experimental Treatment 1 Intervention

Participants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W).

Group IV: Clear Cell Renal Carcinoma (ccRCC) Cohort Experimental Treatment 1 Intervention

Participants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W.

Group V: Cervical Cancer Cohort Experimental Treatment 1 Intervention

Participants with cervical cancer who will receive R-DXd administered intravenously Q3W.

Who Is Running the Clinical Trial?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06660654

NCT06660654 | A Study of Raludotatug Deruxtecan in ... This pan-tumor trial is designed as a signal-seeking trial to assess efficacy and safety of raludotatug deruxtecan (R-DXd) monotherapy in locally advanced ...

2. 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- ...

3. 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.

4. targetedonc.com targetedonc.com/view/r-dxd-elicits-encouraging-efficacy-in-ovarian-cancer

R-DXd Elicits Encouraging Efficacy in Ovarian Cancer R-DXd showed a 50.5% objective response rate in platinum-resistant ovarian cancer, with a 5.6 mg/kg dose deemed optimal for further study. The ...

5. cancernetwork.com cancernetwork.com/view/the-fda-grants-btd-to-r-dxd-in-pretreated-gynecologic-cancers

The FDA Grants BTD to R-DXd in Pretreated Gynecologic ... A study of raludotatug deruxtecan (R-DXd) in subjects with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer.

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 ... Median duration of response (DOR) was 11.2 months (95% CI: 3.0-NE) and median progression-free survival (PFS) was 7.9 months (95% CI: 4.4-12.4) ...