DS-1062a for Non-Small Cell Lung Cancer

Recruiting at 20 trial locations

Overseen By (For Asia sites only) Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Daiichi Sankyo Co., Ltd.

Must not be taking: Steroids, Immunosuppressives

Disqualifiers: Cardiac disease, ILD, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

890 Participants Needed

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.

Do I need to stop my current medications to join the trial?

The trial requires an adequate treatment washout period (time without taking certain medications) before starting the study drug. This means you may need to stop some of your current medications, but the specific details are not provided in the protocol.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a

Approximately 6 months

Multiple visits as per cycle requirements

Dose Expansion

To investigate the safety and tolerability of DS-1062a in additional solid tumors

Approximately 6 months

Multiple visits as per cycle requirements

Sub-study

Compare the effectiveness of steroid versus non-steroid mouthwash as prophylaxis against oral mucositis/stomatitis

Concurrent with Dose Expansion

Randomized study visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• DS-1062a

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