Raludotatug Deruxtecan for Cancer

Recruiting at 7 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

Trial Summary

What is the purpose of this trial?

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 or metastatic solid tumors with various cadherin-6 (CDH6) expression levels, including gynecological cancers (endometrial cancer, cervical cancer, and non-high-grade serous ovarian cancer) and genitourinary cancers (urothelial cancer and clear cell renal cell carcinoma \[ccRCC\]).

Eligibility Criteria

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.

I am 18 years or older.

My cancer has worsened after my last treatment.

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

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

Treatment Details

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.

Participant Groups

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