DS-1062a for Non-Small Cell Lung Cancer

Not currently recruiting at 22 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, DS-1062a, for individuals with non-small cell lung cancer (NSCLC) who have not found success with other treatments. The study aims to determine the safest and most effective dose of the drug and assess its efficacy on various solid tumors, including NSCLC. Those with advanced NSCLC that cannot be treated surgically and who have exhausted standard treatments might qualify for this study. A sub-study will evaluate whether a steroid or non-steroid mouthwash alleviates mouth sores caused by the treatment. The trial occurs in the United States and Japan, and participants may continue as long as they benefit from the treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that DS-1062a is likely to be safe for humans?

Research has shown that DS-1062a was generally well tolerated at doses up to 8 mg/kg in earlier studies. The effects of the treatment varied with the dosage. No serious side effects were reported at these levels, suggesting the drug is generally safe within this range. However, this trial marks the first use of DS-1062a in humans, necessitating ongoing monitoring to fully understand its safety. Participants should be aware that while early results are promising, the treatment's safety in a larger population is still under investigation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

DS-1062a is unique because it targets the TROP2 protein, a feature not commonly addressed by current non-small cell lung cancer treatments like chemotherapy, targeted therapies, or immunotherapies. This innovative approach aims to deliver a more precise attack on cancer cells, potentially leading to more effective outcomes with fewer side effects. Researchers are excited about DS-1062a because it offers a novel mechanism of action that could improve treatment efficacy and provide new hope for patients who have not responded well to existing options.

What evidence suggests that DS-1062a might be an effective treatment for non-small cell lung cancer?

Research has shown that DS-1062a, also known as datopotamab deruxtecan, may help treat non-small cell lung cancer (NSCLC). In earlier studies, patients with advanced NSCLC who received this treatment experienced a longer time before their cancer worsened compared to those who took docetaxel. Additionally, patients generally tolerated this treatment well at doses up to 8 mg/kg, and it noticeably reduced tumor size. These early findings suggest that DS-1062a could be a promising option for those whose cancer hasn't responded to other treatments. ^{1 3 5 6 7}

Who Is on the Research Team?

Global Team Leader

Principal Investigator

Daiichi Sankyo

Are You a Good Fit for This Trial?

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.

My advanced lung cancer cannot be removed by surgery.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-01544

Datopotamab Deruxtecan Versus Docetaxel for Previously ... Dato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04940325

NCT04940325 | Datopotamab Deruxtecan (Dato-DXd, DS ... This study aims to evaluate the efficacy and safety of DS-1062a in participants with metastatic, unresectable NSCLC having progressed on one, but not more ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT312611

Dose escalation and expansion from the phase I study of ... In this first-in-human study of DS-1062, treatment was well tolerated up to 8 mg/kg, and a dose effect on antitumor activity was observed over 2.0-10.0 mg/kg.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10564307/

First-in-Human, Phase I Dose-Escalation ... - PubMed Central This first-in-human, dose-escalation and dose-expansion study evaluated the safety, tolerability, and antitumor activity of datopotamab deruxtecan (Dato-DXd)

5. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-01349

Results From the Phase II TROPION-Lung05 Study Encouraging and durable antitumor activity was observed with Dato-DXd in this heavily pretreated advanced/metastatic NSCLC population with actionable genomic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03401385

NCT03401385 | First-in-human Study of DS-1062a for ... This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments.

7. cancer.gov cancer.gov/clinicaltrials/NCI-2020-11431

Study of DS-1062a in Advanced or Metastatic Non-small ... This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC)