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Trial record 1 of 1 for:    NCT03401385
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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 : June 17, 2020
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE January 17, 2018
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE January 31, 2018
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
  • 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.
  • Number of participants with adverse events (AEs) [ Time Frame: 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
  • 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.
  • 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) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
  • Maximum concentration (Cmax) [ Time Frame: Within 8 cycles (each cycle is 21 days) ]
    Categories: DS-1062a, total anti-TROP2 antibody, MAAA-1181a
  • 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
  • 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
  • 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
  • Minimum observed concentration (Ctrough) [ Time Frame: Within 8 cycles (each cycle is 21 days) ]
    Categories: DS-1062a, total anti-TROP2 antibody, MAAA-1181a
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-human Study of DS-1062a for Advanced Solid Tumors
Official Title  ICMJE Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors
Brief Summary

This study is one single group of participants with non-small cell lung cancer (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 4 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan.

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.
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, participants 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 and/or triple negative breast cancer (TNBC) participants. 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: 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
Condition  ICMJE
  • Carcinoma, Non-Small-Cell Lung
  • Triple Negative Breast Cancer
Intervention  ICMJE Drug: DS-1062a
A total anti-TROP2 antibody and MAAA-1181a
Other Name: Study treatment
Study Arms  ICMJE
  • Experimental: Dose Escalation - All Participants
    All participants enrolled in the dose escalation part
    Intervention: Drug: DS-1062a
  • Experimental: Dose Expansion - All Participants
    All participants enrolled in the dose expansion part
    Intervention: Drug: DS-1062a
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
350
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2018)
132
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has a pathologically documented unresectable advanced NSCLC disease not amenable to curative therapy (NSCLC participants only).
  • Has a pathologically documented advanced/unresectable or metastatic triple negative breast cancer (TNBC participants only).
  • Has relapsed from or is refractory to standard treatment or for which no standard treatment is available.
  • Consents to provide mandatory pre-treatment tumor tissue samples for the measurement of recent TROP2 levels by immunohistochemistry and other biomarkers, which means either an archived sample following the last treatment or a DS1062a pre-treatment biopsy. There is no minimum TROP2 expression level required for inclusion.
  • Consents to undergo mandatory on-treatment biopsy if clinically feasible and not contraindicated at the time of on-treatment biopsy, and consents to provide the tumor tissue samples from on-treatment biopsy for the measurement of TROP2 level and other biomarkers.
  • 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 enrollment.
  • 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/childbearing 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, participants 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 mean corrected QT interval (QTcF) prolongation to >470 ms (females) or >450 ms (males) based on average of the screening triplicate 12-lead ECGs.
  • 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 participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Contact: (For US sites) Daiichi Sankyo Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03401385
Other Study ID Numbers  ICMJE DS1062-A-J101
173812 ( Registry Identifier: JAPIC CTI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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 https://vivli.org/. 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://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all 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, the European Union and/or Japan 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://vivli.org/ourmember/daiichi-sankyo/
Responsible Party Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
Study Sponsor  ICMJE Daiichi Sankyo Co., Ltd.
Collaborators  ICMJE Daiichi Sankyo, Inc.
Investigators  ICMJE
Study Director: Global Team Leader Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP