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Trial record 1 of 1 for:    NCT04145622
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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 : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

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.

This study is expected to last approximately 3.5 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Malignant Solid Tumor Drug: DS-7300a Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II, Two-Part, Multicenter First-in-Human Study of DS-7300a in Subjects With Advanced Solid Malignant Tumors
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Arm Intervention/treatment
Experimental: Dose escalation
All participants enrolled in the dose escalation part
Drug: DS-7300a
A total anti-B7H3 antibody and MAAA-1181a

Experimental: Dose expansion
All participants enrolled in the dose expansion part
Drug: DS-7300a
A total anti-B7H3 antibody and MAAA-1181a




Primary Outcome Measures :
  1. Evaluate the incidence of dose-limiting toxicities (DLTs) [ Time Frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part ]
  2. Evaluate the incidence of adverse events (AEs) [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  3. Investigate the antitumor activity of DS-7300a [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]

Secondary Outcome Measures :
  1. Characterize the PK parameter AUClast [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  2. Characterize the PK parameter AUCtau [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  3. Characterize the PK parameter Cmax [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  4. Characterize the PK parameter Tmax [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  5. Characterize the PK parameter Ctrough [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
  6. 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) ]


Information from the National Library of Medicine

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

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.
  • Has adequate cardiac, hematopoietic, renal and hepatic functions
  • Has an adequate treatment washout period prior to start of study treatment

Additional Inclusion Criteria for Part 1 (Dose Escalation)

  • 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), bladder cancer, sarcoma, endometrial cancer, melanoma, prostate cancer, breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.

Additional Inclusion Criteria for Part 2 (Dose Expansion)

  • Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous-NSCLC that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Additional or alternative indications may be added to expansion cohorts based on preliminary signals of activity in dose escalation via a protocol amendment.

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, 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 medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association classes II-IV), unstable angina or serious cardiac arrhythmia.
  • 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.

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): NCT04145622


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

Locations
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United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37205
Contact: Principal Investigator         
Japan
National Cancer Center Hospital East Recruiting
Chiba, Japan, 277-8577
Contact: See Central Contact         
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104-0045
Contact: See Central Contact         
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT04145622     History of Changes
Other Study ID Numbers: DS7300-A-J101
194992 ( Other Identifier: JapicCTI )
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
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 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
Statistical Analysis Plan (SAP)
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/

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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. ):
Advanced Solid Tumor
Malignant Tumor
DS-7300a
Additional relevant MeSH terms:
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Neoplasms