DS-6000a for Kidney and Ovarian Cancer

Recruiting at 14 trial locations

Overseen By (US sites) Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Daiichi Sankyo

Must not be taking: Corticosteroids

Disqualifiers: CNS metastases, Multiple malignancies, Heart failure, others

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

Compensation: Varies

Number of Visits: 2

179 Participants Needed

Trial Summary

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

The trial requires an adequate treatment washout period (time without taking certain medications) before starting the study treatment, but it doesn't specify which medications need to be stopped. It's best to discuss your current medications with the trial team to understand what changes might be needed.

How is the drug DS-6000a different from other treatments for kidney and ovarian cancer?

The drug DS-6000a may offer a unique approach compared to standard treatments for ovarian cancer, as it could potentially be administered intraperitoneally (directly into the abdominal cavity), which has shown to enhance drug concentration and effectiveness in similar treatments like cisplatin and paclitaxel for ovarian cancer. This method can lead to better outcomes by increasing the drug's exposure to the tumor, which is not typically achieved with standard intravenous treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new medicine called R-DXd for patients with advanced kidney and ovarian cancers. The medicine targets cancer cells, gets inside them, and releases a drug that stops their growth and kills them. The study aims to find the safest dose and see how well it works.

Research Team

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

This trial is for adults with advanced kidney cancer or ovarian tumors who can consent, use effective contraception, have a good performance status (able to carry out daily activities), and proper heart function. They must not have had certain previous cancer treatments, multiple cancers unless cured over 3 years ago, recent serious heart issues, significant lung illnesses, uncontrolled infections or brain metastases.

Inclusion Criteria

I am fully active or can carry out light work.

Has an adequate treatment washout period prior to start of study treatment

I have stored samples of my tumor available.

Exclusion Criteria

I am currently fighting an infection that needs treatment.

I had a heart attack or unstable chest pain within the last 6 months.

I have been treated with a specific type of cancer drug related to trastuzumab.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants with ovarian cancer (OVC) or renal cell carcinoma (RCC) receive an intravenous infusion of R-DXd to assess safety and determine the maximum tolerated dose

21 days per cycle, up to several cycles

1 visit every 21 days

Dose Expansion

Participants receive R-DXd at the recommended dose to evaluate clinical activity

21 days per cycle, up to several cycles

1 visit every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 52 months

Treatment Details

Interventions

• DS-6000a

Trial Overview The study tests DS-6000a (Raludotatug Deruxtecan) in patients with advanced renal cell carcinoma and ovarian cancer. It aims to find the safest dose of R-DXd that participants can take while also evaluating its side effects and effectiveness against these cancers.

Participant Groups

Group I: Dose Expansion: Cohort B-2 Experimental Treatment 1 Intervention

Participants with OVC will receive an intravenous infusion of R-DXd at the RDE.

Group II: Dose Expansion: Cohort B-1 Experimental Treatment 1 Intervention

Participants with RCC will receive an intravenous infusion of R-DXd at the RDE. Enrollment has ended for this cohort.

Group III: Dose Escalation Experimental Treatment 1 Intervention

Participants with ovarian cancer (OVC) or renal cell carcinoma (RCC) will receive an intravenous infusion of R-DXd (starting dose 1.6 mg/kg).

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

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

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

Findings from Research

Docetaxel has shown comparable effectiveness to paclitaxel when combined with carboplatin for treating advanced ovarian cancer, with a potentially better safety profile.

Current treatments for platinum-resistant ovarian cancer are limited, and while some experimental therapies targeting the epidermal growth factor receptor show promise, more research is needed to find effective new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New aspects by the therapy of ovarian cancer--What changes after the ASCO-Meeting 2001]. Costa, SD., von Minckwitz, G., Wernicke, K., et al.[2008]

Patients with recurrent ovarian cancer are categorized as either platinum-sensitive or platinum-resistant, which influences treatment options; platinum-sensitive patients often benefit from re-treatment with paclitaxel/platinum combinations, while platinum-resistant patients may receive single-agent therapies like altretamine or topotecan.

For platinum-sensitive patients with minimal residual disease, intensive intraperitoneal therapy with cisplatin and paclitaxel shows the most promise for long-term disease-free survival, highlighting the importance of tailored treatment strategies based on disease characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of refractory and recurrent ovarian cancer. Alberts, DS.[2005]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Intraperitoneal drug delivery of antineoplastics. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Point: Intraperitoneal chemotherapy in the management of ovarian cancer. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[New aspects by the therapy of ovarian cancer--What changes after the ASCO-Meeting 2001]. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of refractory and recurrent ovarian cancer. [2005]

5. England pubmed.ncbi.nlm.nih.gov

Intraperitoneal antineoplastic drug delivery: rationale and results. [2022]