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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

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

Study 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.

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

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).

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Daiichi SankyoLead Sponsor

392 Previous Clinical Trials

416,225 Total Patients Enrolled

Daiichi Sankyo, Inc.Lead Sponsor

389 Previous Clinical Trials

420,157 Total Patients Enrolled

Global Clinical LeaderStudy DirectorDaiichi Sankyo

162 Previous Clinical Trials

78,998 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What precautions should be taken when utilizing DS-6000a?

"Taking into consideration that DS-6000a is in its primary testing phase, our risk assessment predicts a score of 1 for the drug's safety profile. This implies that there has been limited data on both efficacy and hazard."

Answered by AI

What is the sample size of this clinical trial?

"Affirmative. Data found on clinicaltrials.gov reveals that the medical trial, first posted in December 22nd 2020, is actively searching for participants. The study requires 110 patients to be enrolled from 4 distinct sites."

Answered by AI

Are the enrollment parameters for this research project still open?

"Affirmative. The clinical trial database hosted on clinicaltrials.gov reveals that recruitment for this experiment is ongoing and began on December 22nd 2020 with the latest update made on November 15th 2022. 110 participants from 4 different sites are required to complete the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

2020. "A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04707248.

All > Renal Cell Carcinoma