DS-1062a for Non-Small Cell Lung Cancer

Recruiting at19 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Daiichi Sankyo Co., Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, DS-1062a, on patients with advanced cancers who haven't been cured by other treatments. The goal is to find the safest dose and see if the drug can help treat these cancers.

Research Team

Global Team Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

This trial is for adults with various advanced solid tumors, including non-small cell lung cancer and breast cancer, that have not responded to standard treatments. Participants must have measurable disease, adequate organ function, agree to use contraception if of childbearing potential, and be willing to provide tissue samples. They should not have had certain prior treatments or conditions that would exclude them from the study.

Inclusion Criteria

I have had a break from previous treatments before starting this new treatment cycle.

My head/neck cancer can't be removed by surgery and was treated with 1-3 therapies including platinum and immunotherapy.

If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug, and agrees not to retrieve, freeze or donate sperm or ova starting at Screening and throughout the study period, and at least 7 months for males and 4 months for males after the final study drug administration

Exclusion Criteria

I do not have active symptoms from brain metastases or spinal cord compression.

Is lactating or pregnant as confirmed by pregnancy tests performed within 7 days before enrollment

I still have side effects from past cancer treatments.

Treatment Details

Interventions

• DS-1062a (Monoclonal Antibodies)

Trial Overview The trial is testing a new drug called Datopotamab Deruxtecan (Dato-DXd) in humans for the first time. It includes dose escalation to find the safest dose and expansion phases across different tumor types over approximately six years. A sub-study compares steroid versus non-steroid mouthwash in preventing oral mucositis in participants receiving Dato-DXd.

Participant Groups

Group I: Dose Expansion - All Participants Experimental Treatment 3 Interventions

All participants enrolled in the dose expansion part

Group II: Dose Escalation - All Participants Experimental Treatment 1 Intervention

All participants enrolled in the dose escalation part

Who Is Running the Clinical Trial?

Daiichi Sankyo Co., Ltd.

Lead Sponsor

Trials

116

Recruited

49,200+

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Daiichi Sankyo, Inc.

Industry Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology