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DS-1062a for Breast Cancer

Phase-Based Progress Estimates

Effectiveness

Safety

Breast Cancer+5 More

DS-1062a - Drug

You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.

Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial is studying a new drug, DS-1062a, for safety and tolerability in people with NSCLC that has not been cured by other treatments. The trial will be in two parts, with the first part looking at dose escalation and the second part looking at additional solid tumors. The trial is expected to last approximately 6 years and will be conducted in the United States and Japan.

Eligible Conditions

Breast Cancer
Breast Cancer (Triple Negative Breast Cancer (TNBC))
Hormone Receptor (HR)-Positive Breast Cancer
Non-small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Datopotamab deruxtecan

Pembrolizumab

Datopotamab deruxtecan

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: When all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)

At 8 weeks

Stomatitis

Year 4

Number of participants with adverse events (AEs)

Day 21

AUC during the dosing period (AUCtau)

Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)

Maximum concentration (Cmax)

Minimum observed concentration (Ctrough)

Time at which Cmax is reached (Tmax)

Day 21

Number of participants with dose-limiting toxicities

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Cancer

Datopotamab deruxtecan

Pembrolizumab

Datopotamab deruxtecan

Trial Design

2 Treatment Groups

Dose Expansion - All Participants

1 of 2

Dose Escalation - All Participants

1 of 2

Experimental Treatment

770 Total Participants · 2 Treatment Groups

Primary Treatment: DS-1062a · No Placebo Group · Phase 1

Dose Expansion - All ParticipantsExperimental Group · 4 Interventions: DS-1062a, Steroid Containing Mouthwash, Non-Steroid Containing Mouthwash, Datopotamab Deruxtecan (Dato-DXd) · Intervention Types: Drug, Drug, Other, Drug

Dose Escalation - All ParticipantsExperimental Group · 2 Interventions: DS-1062a, Datopotamab Deruxtecan (Dato-DXd) · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: when all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)

Who is running the clinical trial?

Daiichi Sankyo, Inc.Industry Sponsor

355 Previous Clinical Trials

339,737 Total Patients Enrolled

18 Trials studying Breast Cancer

14,003 Patients Enrolled for Breast Cancer

AstraZenecaIndustry Sponsor

3,956 Previous Clinical Trials

91,808,099 Total Patients Enrolled

158 Trials studying Breast Cancer

1,235,894 Patients Enrolled for Breast Cancer

Daiichi Sankyo Co., Ltd.Lead Sponsor

113 Previous Clinical Trials

47,990 Total Patients Enrolled

4 Trials studying Breast Cancer

1,934 Patients Enrolled for Breast Cancer

Global Team LeaderStudy DirectorDaiichi Sankyo, Inc.

6 Previous Clinical Trials

1,539 Total Patients Enrolled

3 Trials studying Breast Cancer

1,223 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

You have relapsed or progressed following local standard treatments or for which no standard treatment is available.

You have a minimum age of 18 years old.

You have an Eastern Cooperative Oncology Group performance status of 0-1.

You have not had a complete treatment washout period prior to Cycle 1, Day 1.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References