What side effects are associated with this type of intervention?

Common treatments for kidney cancer, such as targeted therapies (e.g., sunitinib, sorafenib) and immunotherapies (e.g., nivolumab, pembrolizumab), often have side effects including hypertension, fatigue, hand-foot syndrome, rash, and gastrointestinal issues. Antibody-drug conjugates like Raludotatug Deruxtecan may also cause myelosuppression, nausea, and interstitial lung disease. These treatments aim to target cancer cells specifically but can still affect healthy cells, leading to a range of adverse effects.

What prior FDA approvals exist?

Several FDA-approved treatments for kidney cancer include targeted therapies and immunotherapies. Notably, antibody-drug conjugates like Raludotatug Deruxtecan are being studied for their targeted approach to cancer cells. Pembrolizumab, an immune checkpoint inhibitor, has shown efficacy in metastatic renal cell carcinoma. Atezolizumab combined with Bevacizumab, another immunotherapy regimen, has also been approved for advanced renal cell carcinoma. These treatments focus on targeting specific pathways or proteins on cancer cells, similar to the mechanism of antibody-drug conjugates.

What other types of research exist?

Promising alternatives to Raludotatug Deruxtecan for kidney cancer patients include: <ol> <li>Pembrolizumab: Demonstrated efficacy in metastatic sarcomatoid RCC with objective response rates of 64% and 42% in different cohorts.</li> <li></li> </ol> Atezolizumab plus Bevacizumab: Showed a trend towards improved overall survival in advanced RCC. 3. Cabozantinib in combination with Atezolizumab: Results from the COSMIC-021 study indicate potential benefits for advanced RCC. 4. Nivolumab and Ipilimumab: Combination therapy has shown efficacy in advanced RCC in various studies. 5. AGS-003: An autologous dendritic cell-based immunotherapy combined with sunitinib has shown survival benefits in phase 2 studies.

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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 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.

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.

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.

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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Dose Expansion)

Secondary study objectives

Clinical Benefit Rate (CBR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review

Disease Control Rate (DCR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review

Duration of Response (DoR) Based on RECIST v1.1 Per Investigator and Blinded Independent Central Review

+1 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. Enrollment has ended for this cohort.

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).

0 / 8Eligibility criteria met

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.