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First-in-human Study of DS-1062a for Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03401385
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : February 22, 2018
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:

This study is one single group of participants with NSCLC who have not been cured by other treatments. It is the first time the drug has been used in humans, and will be in two parts.

The primary purpose of the parts are:

  • 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
  • Dose Expansion: To investigate the safety and tolerability of DS-1062a

This study is expected to last approximately 2.5 years from the time the first subject is enrolled to the time the last subject is off the study.

The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:

  • they withdraw
  • their disease gets worse
  • they experience unacceptable side effects.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: DS-1062a Phase 1

Detailed Description:

The dosage strength will change during the study but all participants will receive the same study drug. So the study is not a true 2-arm study, it is a 2-part study.

In both parts, subjects with pathologically documented unresectable advanced NSCLC who have been refractory to or relapsed from standard treatment or for which no standard treatment is available, will be enrolled. Additional solid tumors might be evaluated, if the study treatment demonstrates acceptable safety, tolerability and efficacy in NSCLC patients. After the primary analysis, the main (registered) study will be considered complete, but data will be collected from participants who continue receiving study drug.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single group, but in two study parts, therefore two sequential arms are identified
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Two-part, Multicenter, Non-randomized, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : June 20, 2021
Estimated Study Completion Date : June 20, 2021

Arm Intervention/treatment
Experimental: Dose Escalation - All Participants
All participants enrolled in the dose escalation part
Drug: DS-1062a
A total anti-TROP2 antibody and MAAA-1181a
Other Name: Study treatment
Experimental: Dose Expansion - All Participants
All participants enrolled in the dose expansion part
Drug: DS-1062a
A total anti-TROP2 antibody and MAAA-1181a
Other Name: Study treatment

Primary Outcome Measures :
  1. Number of participants with dose-limiting toxicities [ Time Frame: Within 8 cycles (each cycle is 21 days) ]
    Dose-limiting toxicities are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

  2. Number of participants with adverse events (AEs) [ Time Frame: When all subjects have either discontinued the study or the last subject enrolled in the study has completed at least 6 months of follow up (approximately 2.5 years) ]

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: Within 8 cycles (each cycle is 21 days) ]
    Categories: DS-1062a, total anti-TROP2 antibody, MAAA-1181a

  2. Time at which Cmax is reached (Tmax) [ Time Frame: Within 8 cycles (each cycle is 21 days) ]
    Categories: DS-1062a, total anti-TROP2 antibody, MAAA-1181a

  3. Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast) [ Time Frame: Within 8 cycles (each cycle is 21 days) ]
    Categories: DS-1062a, total anti-TROP2 antibody, MAAA-1181a

  4. AUC to the end of the dosing period (AUCtau) [ Time Frame: Within 8 cycles (each cycle is 21 days) ]
    Categories: DS-1062a, total anti-TROP2 antibody, MAAA-1181a

  5. Minimum observed concentration (Ctrough) [ Time Frame: Within 8 cycles (each cycle is 21 days) ]
    Categories: DS-1062a, total anti-TROP2 antibody, MAAA-1181a

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has a pathologically documented unresectable advanced NSCLC disease not amenable to curative therapy
  • Has relapsed from or is refractory to standard treatment or for which no standard treatment is available
  • Consents to provide tumor tissue sample for the measurement of recent TROP2 levels by immunohistochemistry, which means archived sample following last treatment or pre-DS1062a treatment biopsy (there is no minimum TROP2 expression level required for inclusion)
  • Is aged ≥20 years old in Japan or ≥18 years old in other countries
  • Has an Eastern Cooperative Oncology Group performance status 0-1
  • Has a left ventricular ejection fraction (LVEF) ≥50% by either an ECHO or MUGA within 28 days before registration
  • Has measurable disease based on RECIST version1.1
  • Has adequate organ function within 7 days before enrollment
  • Has an adequate treatment washout period prior to enrollment
  • If of reproductive potential, agrees to use a highly effective from of contraception or avoid intercourse during and upon completion of the study and for at least 4 months 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 4 months after the final study drug administration
  • After being fully informed about their illness and the investigative nature of the protocol (including foreseeable risks and possible toxicities), is willing and able comply with the protocol and to provide written, ethics committee-approved informed consent form before performance of any study-specific procedures or examinations
  • Has a life expectancy of ≥3 months
  • If the study Sponsor decides to evaluate additional solid tumors, subjects must satisfy following criteria to be included in the study: Has a pathologically documented advanced solid tumor.

Exclusion Criteria:

  • Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years
  • Has a history of myocardial infarction or unstable angina within 6 months before enrollment
  • Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment Has a corrected QT by Fridericia's formula (QTcF), of >470 ms based on a triplicate 12-lead ECG
  • Has clinically significant lung disease or is suspected to have such diseases by imaging at Screening
  • Has clinically significant corneal disease
  • Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Has active human immunodeficiency virus infection that is uncontrolled (increasing plasma HIV RNA viral load) with medication, or has an active hepatitis B or C infection
  • Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms (participants with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy)
  • Is lactating or pregnant as confirmed by pregnancy tests performed within 7 days before enrollment
  • Has unresolved toxicities from previous anticancer therapy
  • Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator
  • Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product
  • Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401385

Contact: (For Asia sites only) Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Principal Investigator       Alexander.Spira@USOncology.com   
National Cancer Center Hospital Recruiting
Chuo Ku, Tokyo, Japan, 104-0045
Contact: see Central Contact         
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.
Study Director: Global Team Leader Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT03401385     History of Changes
Other Study ID Numbers: DS1062-A-J101
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States and the European Union from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Non-small cell lung cancer
Other solid tumors

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases