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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 : November 22, 2022
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Ovarian Cancer Germ Cell Tumor Drug: DS-9606a Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation and dose expansion study model
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 (CLDN6)
Actual Study Start Date : May 31, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation: DS-9606a
Participants who will receive an intravenous (IV) dose of DS9606a starting at 0.016 mg/kg every 3 weeks.
Drug: DS-9606a
Intravenous infusion

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.
Drug: DS-9606a
Intravenous infusion

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.
Drug: DS-9606a
Intravenous infusion




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]


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:

  • 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

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): NCT05394675


Contacts
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Contact: Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com

Locations
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United States, Colorado
SCRI at HealthONE Recruiting
Denver, Colorado, United States, 80216
Contact: Principal Investigator         
United States, Florida
Florida Cancer Specialists & Research Institute, LLC Recruiting
Sarasota, Florida, United States, 33916
Contact: Principal Investigator         
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Principal Investigator         
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Principal Investigator         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Principal Investigator         
United Kingdom
The Royal Marsden NHS Trust Not yet recruiting
London, United Kingdom, SM2 5PT
Contact: Principal Investigator         
Sarah Cannon Research Institute UK Recruiting
London, United Kingdom, W1G 6AD
Contact: Principal Investigator         
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Clinical Director Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT05394675    
Other Study ID Numbers: DS9606-137
2022-000120-38 ( EudraCT Number )
REFMAL 823 ( Other Identifier: Sarah Cannon Development Innovations, LLC] )
First Posted: May 27, 2022    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
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)
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/

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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.:
Advanced Cancer
Metastatic Cancer
Ovarian Cancer
Germ Cell Tumor
DS-9606a
Additional relevant MeSH terms:
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Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes