We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of DS-9606a in Patients 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: NCT05394675
Recruitment Status : Recruiting
First Posted : May 27, 2022
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE May 24, 2022
First Posted Date  ICMJE May 27, 2022
Last Update Posted Date January 13, 2023
Actual Study Start Date  ICMJE May 31, 2022
Estimated Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2022)
  • Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a [ Time Frame: Cycle 1 Day 1 through Day 21 of Cycle 2 (each cycle is 21 days) ]
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-9606a [ Time Frame: Cycle 1 Day 1 to 30 days after last dose, up to 36 months (each cycle is 21 days) ]
  • Overall Response Rate of DS-9606a as Assessed by the Investigator in Participants Receiving DS-9606a (Dose Expansion) [ Time Frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2022)
  • Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) [ Time Frame: Cycles 1-3, Day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (Cycles 1 and 3 only); Cycle 1 and 3,Day 2; Cycle 1 and 3,Days 4,8, and 15; Cycle 2,Days 8 and 15; Cycle 4,Day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days) ]
  • Pharmacokinetic Parameter Maximum Concentration (Cmax) [ Time Frame: Cycles 1-3, Day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (Cycles 1 and 3 only); Cycle 1 and 3,Day 2; Cycle 1 and 3,Days 4,8, and 15; Cycle 2,Days 8 and 15; Cycle 4,Day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days) ]
  • Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) [ Time Frame: Cycles 1-3, Day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (Cycles 1 and 3 only); Cycle 1 and 3,Day 2; Cycle 1 and 3,Days 4,8, and 15; Cycle 2,Days 8 and 15; Cycle 4,Day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days) ]
  • Pharmacokinetic Parameter Trough Concentration (Ctrough) [ Time Frame: Cycles 1-3, Day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (Cycles 1 and 3 only); Cycle 1 and 3,Day 2; Cycle 1 and 3,Days 4,8, and 15; Cycle 2,Days 8 and 15; Cycle 4,Day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days) ]
  • Duration of Response (DoR) as Assessed by the Investigator in Participants Receiving DS-9606a [ Time Frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) ]
  • Disease Control Rate (DCR) as Assessed by the Investigator in Participants Receiving DS-9606a [ Time Frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) ]
  • Time to Response (TTR) as Assessed by the Investigator in Participants Receiving DS-9606a [ Time Frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) ]
  • Progression-free Survival (PFS) as Assessed by the Investigator in Participants Receiving DS-9606a [ Time Frame: Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) ]
  • Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Percentage of Participants Who Have Treatment-emergent ADA [ Time Frame: Cycle 1 Days 1 and 15, Cycles 2 and 3 Day 1, Cycle 4 Day 1 and all cycles thereafter on Day 1, up to 36 months (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 A Study of DS-9606a in Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase 1, First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 (CLDN6)
Brief Summary This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.
Detailed Description

This first-in-human, phase 1 study will consist of 2 parts. In Part A (Dose Escalation), the primary objectives will be to investigate the safety and tolerability of DS-9606a in advanced solid tumors and to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE). In Part B (Dose Expansion), the safety and tolerability of DS-9606a will be further explored and the overall response rate will be assessed.

The secondary objectives of the study will assess pharmacokinetic properties of DS-9606a and investigate the duration of response and progression-free survival of DS-9606a, and assess the immunogenicity of DS-9606a.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Dose escalation and dose expansion study model
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Metastatic Cancer
  • Ovarian Cancer
  • Germ Cell Tumor
Intervention  ICMJE Drug: DS-9606a
Intravenous infusion
Study Arms  ICMJE
  • Experimental: Dose Escalation: DS-9606a
    Participants who will receive an intravenous (IV) dose of DS9606a starting at 0.016 mg/kg every 3 weeks.
    Intervention: Drug: DS-9606a
  • Experimental: Dose Expansion: Cohort B-1
    Participants with ovarian cancer who will receive an intravenous (IV) dose of DS9606a at the recommended dose for expansion (RDE) every 3 weeks.
    Intervention: Drug: DS-9606a
  • Experimental: Dose Expansion: Cohort B-2
    Participants with refractory germ cell tumors who will receive an intravenous (IV) dose of DS9606a at the recommended dose for expansion (RDE) every 3 weeks.
    Intervention: Drug: DS-9606a
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 24, 2022)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2023
Estimated Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years old at the time of written informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Availability of archived tumor tissue samples (mandatory); patients with germ cell tumors without archived tumor samples may be allowed with approval
  • Has a left ventricular ejection fraction (LVEF) ≥50% as determined by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before the start of study treatment
  • Adequate bone marrow and organ function within 7 days before the start of study treatment
  • Life expectancy ≥3 months
  • Adequate treatment washout period prior to start of study treatment
  • Male patients with female partners of childbearing potential and female patients of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 4 months (for males) and for at least 7 months (for females) after the last dose of study drug. Males must agree not to freeze or donate sperm throughout the study period for at least 4 months after final administration of study drug. Females must agree not to donate or retrieve ova for own use throughout the study period and for at least 7 months after final study drug administration.

Dose Escalation Participants Only:

  • Histologically- or cytologically-documented locally advanced or metastatic cancers, including but not limited to: ovarian cancer (including fallopian tube and primary peritoneal carcinoma), germ cell tumors, uterine and endometrial cancers, pancreatic adenocarcinoma, non-squamous NSCLC, or gastric cancer
  • Disease progression with standard of care therapies for metastatic disease known to confer benefit, or are intolerant to or refuse standard treatment.

Dose Expansion Participants Only:

  • Consent to provide pre-treatment (mandatory) and on-treatment tissue biopsy sample (mandatory if not clinically contraindicated)
  • Histologically or cytologically-documented locally advanced or metastatic cancers including:

    • Cohort B-1: Ovarian cancer
    • Cohort B-2: Refractory germ cell tumors

Exclusion Criteria:

  • Has history or current presence of central nervous system metastases, except for participants who have completed radiotherapy or surgery ≥4 weeks before the start of treatment, and fulfill all criteria (no evidence of disease progression in the CNS and no requirement for chronic corticosteroids) within 2 weeks before the start of treatment
  • Other invasive malignancy within 2 years; prior or concurrent non-invasive malignancies and/or patients with localized malignancies that were treated with curative intent who remain disease-free and are considered low likelihood for recurrence may be enrolled
  • History of myocardial infarction or unstable angina within 6 months before study treatment
  • Has a history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment
  • Has a corrected QT interval by Fridericia's formula (QTcF), of >470 ms based on the average of triplicate 12-lead electrocardiogram (ECG) per local read
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Has an uncontrolled infection requiring ongoing or long-term therapy
  • Has a known active hepatitis or uncontrolled hepatitis B or C infection
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: Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05394675
Other Study ID Numbers  ICMJE DS9606-137
2022-000120-38 ( EudraCT Number )
REFMAL 823 ( Other Identifier: Sarah Cannon Development Innovations, LLC] )
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: Informed Consent Form (ICF)
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/
Current Responsible Party Daiichi Sankyo, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Director Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date January 2023

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