DS-1062a for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+5 More
DS-1062a - Drug
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

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

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 preview

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.