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Monoclonal Antibodies

DS-6000a for Kidney and Ovarian Cancer

Phase 1
Recruiting
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group Performance Status score of 0 or 1
At least 18 years of age
Must not have
Has an uncontrolled infection requiring systemic therapy
Has had prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, DS-1062a, DS-7300a)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first documented response to date of progression or death due to any cause (whichever occurs first), up to approximately 24 months
Awards & highlights

Summary

This trial will test a new drug, DS-6000a, on patients with advanced kidney or ovarian cancer. The goal is to find the safe dosage, assess side effects, and evaluate effectiveness.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of DS-6000a are not listed here, similar drugs often cause reactions at the infusion site, fatigue, nausea, lowered blood counts increasing infection risk; organ inflammation; hair loss; and potential heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I have stored samples of my tumor available.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently fighting an infection that needs treatment.
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I have been treated with a specific type of cancer drug related to trastuzumab.
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I have been treated with drugs targeting CDH6 before.
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I have no serious lung illnesses besides my cancer.
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I have had serious heart failure or heart rhythm problems that needed treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first documented response to date of progression or death due to any cause (whichever occurs first), up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first documented response to date of progression or death due to any cause (whichever occurs first), up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Reporting Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest
Number of Participants With Dose-limiting toxicities (DLTs)
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Dose Expansion)
Secondary outcome measures
Clinical Benefit Rate (CBR) Based on RECIST v1.1
Disease Control Rate (DCR) Based on RECIST v1.1
Duration of Response (DoR) Based on RECIST v1.1
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose Expansion: Cohort B-2Experimental Treatment1 Intervention
Participants with OVC will receive an intravenous infusion of R-DXd at the RDE.
Group II: Dose Expansion: Cohort B-1Experimental Treatment1 Intervention
Participants with RCC will receive an intravenous infusion of R-DXd at the RDE.
Group III: Dose EscalationExperimental Treatment1 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).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for kidney cancer include antibody-drug conjugates (ADCs) like Raludotatug Deruxtecan, immune checkpoint inhibitors, and VEGF inhibitors. ADCs work by targeting cancer cells with a specific antibody linked to a cytotoxic drug, ensuring that the drug is delivered directly to the cancer cells, thereby reducing harm to normal cells. Immune checkpoint inhibitors, such as pembrolizumab, enhance the body's immune response against cancer cells by blocking proteins that inhibit immune activity. VEGF inhibitors, like sunitinib, block the vascular endothelial growth factor pathway, which tumors use to develop new blood vessels, thereby starving the tumor of nutrients. These mechanisms are crucial for kidney cancer patients as they offer targeted and effective treatment options, potentially leading to better outcomes and fewer side effects.
Current management and future directions in the treatment of advanced renal cell carcinoma-a latin american perspective: 10 years in review.

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Who is running the clinical trial?

Daiichi SankyoLead Sponsor
396 Previous Clinical Trials
419,848 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
421,325 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
162 Previous Clinical Trials
80,226 Total Patients Enrolled

Media Library

DS-6000a (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04707248 — Phase 1
Kidney Cancer Research Study Groups: Dose Escalation, Dose Expansion: Cohort B-1, Dose Expansion: Cohort B-2
Kidney Cancer Clinical Trial 2023: DS-6000a Highlights & Side Effects. Trial Name: NCT04707248 — Phase 1
DS-6000a (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04707248 — Phase 1
~9 spots leftby Oct 2024