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Study of DS-7300a in Participants With Advanced Solid Malignant Tumors

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ClinicalTrials.gov Identifier: NCT04145622
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE October 17, 2019
First Posted Date  ICMJE October 30, 2019
Last Update Posted Date September 9, 2021
Actual Study Start Date  ICMJE November 3, 2019
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Evaluate the incidence of dose-limiting toxicities (DLTs) [ Time Frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part ]
  • Evaluate the incidence of adverse events (AEs) [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  • Investigate the antitumor activity of DS-7300a [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Characterize the PK parameter AUClast [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  • Characterize the PK parameter AUCtau [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  • Characterize the PK parameter Cmax [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  • Characterize the PK parameter Tmax [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  • Characterize the PK parameter Ctrough [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  • Assess the incidence of anti-drug antibodies (ADAs) [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
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 Study of DS-7300a in Participants With Advanced Solid Malignant Tumors
Official Title  ICMJE Phase I/II, Two-Part, Multicenter First-in-Human Study of DS-7300a in Subjects With Advanced Solid Malignant Tumors
Brief Summary

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

The primary purpose of the parts are:

  • Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of DS-7300a.
  • Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of DS-7300a when administered as a single agent.

This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumor
  • Malignant Solid Tumor
Intervention  ICMJE Drug: DS-7300a
A total anti-B7H3 antibody and MAAA-1181a
Study Arms  ICMJE
  • Experimental: Dose escalation
    All participants enrolled in the dose escalation part
    Intervention: Drug: DS-7300a
  • Experimental: Dose expansion
    All participants enrolled in the dose expansion part
    Intervention: Drug: DS-7300a
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: September 1, 2021)
180
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2019)
160
Estimated Study Completion Date  ICMJE October 1, 2023
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Castrate-resistant prostate cancer (CRPC) participants with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.
  • Has adequate cardiac, hematopoietic, renal and hepatic functions
  • Has an adequate treatment washout period prior to start of study treatment
  • Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.

Exclusion Criteria:

  • Has prior treatment with B7-H3 targeted agent.
  • Has prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan).
  • Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
  • Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association classes II-IV), unstable angina or serious cardiac arrhythmia.
  • Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and pleural effusion.
  • Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjögren's, sarcoidosis) where there is documented, or a suspicion of pulmonary involvement at the time of screening.
  • Prior complete pneumonectomy.
  • Has an uncontrolled infection requiring systemic therapy.
  • Has clinically significant pulmonary compromise or requirement for supplemental oxygen.
  • 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.
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: (Japan sites) Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp
Contact: (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 NCT04145622
Other Study ID Numbers  ICMJE DS7300-A-J101
194992 ( Other Identifier: JapicCTI )
Has Data Monitoring Committee No
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 Not Provided
Investigators  ICMJE
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date September 2021

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