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First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05875168
Recruitment Status : Not yet recruiting
First Posted : May 25, 2023
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Metastatic Solid Tumor Drug: DS-3939a Phase 1 Phase 2

Detailed Description:
DS-3939a is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).
Study Design
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Study Type : Interventional
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : March 17, 2026
Estimated Study Completion Date : July 11, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation (Part 1)
Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a.
 Drug: DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
Experimental: Dose Expansion (Part 2)
Multiple expansion cohorts targeting various advanced solid tumors.
 Drug: DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a [ Time Frame: Approximately 3 months after first dosing ]
  2. Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a [ Time Frame: Up to approximately 31 months ]
  3. Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2) [ Time Frame: Up to approximately 31 months ]

Secondary Outcome Measures :
  1. Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1) [ Time Frame: Up to approximately 31 months ]
  2. Disease Control Rate Following Treatment With DS-3939a [ Time Frame: Up to approximately 31 months ]
  3. Duration of Response Following Treatment With DS-3939a [ Time Frame: Up to approximately 31 months ]
  4. Time to Response Following Treatment With DS-3939a [ Time Frame: Up to approximately 31 months ]
  5. Progression Free Survival Following Treatment With DS-3939a [ Time Frame: Up to approximately 31 months ]
  6. Overall Survival Following Treatment With DS-3939a [ Time Frame: Up to approximately 31 months ]
  7. TA-MUC1 Expression by Immunohistochemistry Following Treatment With DS-3939a [ Time Frame: At Cycle 1 Day 1 ]
  8. Area Under the Plasma Concentration Curve (AUC) Following Treatment With DS-3939a [ Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days) ]
  9. Maximum Plasma Concentration (Cmax) Following Treatment With DS-3939a [ Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days) ]
  10. Time to Maximum Plasma Concentration (Tmax) Following Treatment With DS-3939a [ Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days) ]
  11. Minimum Observed Concentration (Ctrough) Following Treatment With DS-3939a [ Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days) ]
  12. Terminal Half-Life (T1/2) Following Treatment With DS-3939a [ Time Frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days) ]
  13. Number of Participants With Treatment-emergent Anti-drug Antibodies Following Treatment With DS-3939a [ Time Frame: Up to approximately 47 months ]

Eligibility Criteria
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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:

  • Sign and date the Informed Consent Form (ICF).
  • Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.
  • Has adequate organ function.
  • Measurable disease based on RECIST V1.1.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.

Additional inclusion criteria for Part 1

  • Has a histologically or cytologically documented locally advanced, metastatic, or unresectable urothelial, non-small cell lung, breast, ovarian, or biliary tract cancers, or pancreatic ductal adenocarcinoma, regardless of any molecular subtypes.

Additional inclusion criteria for Part 2

  • Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy.

  • Is able to provide either of the following baseline tumor samples:

    • Fresh core needle biopsy samples obtained during the Screening Period, or
    • Alternative FFPE tumor tissue samples obtained by biopsy or surgery performed after the completion date of the most recent anticancer therapy regimen and within 6 months before signing the ICF

Exclusion Criteria:

  • Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
  • Has spinal cord compression or history of/clinically active central nervous system metastases.
  • Has multiple primary malignancies, except adequately resected nonmelanoma 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 noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
  • Has active human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid viral load and cluster of differentiation 4 count.
  • Has evidence of active hepatitis B virus or hepatitis C virus infection.
  • Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
  • Has an active, known, or suspected autoimmune disease.
  • Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.
Contacts and Locations
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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): NCT05875168


Contacts
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Contact: (US Sites) Daiichi Sankyo Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com
Contact: (Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111 (M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
More Information
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT05875168    
Other Study ID Numbers: DS3939-077
First Posted: May 25, 2023    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) on completed studies 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)
Informed Consent Form (ICF)
Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and 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 on completed 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.:
DS-3939a
anti-body drug conjugate
advanced/metastatic solid tumors
Additional relevant MeSH terms:
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Neoplasms