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Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant 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: NCT04145622
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : May 16, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Daiichi Sankyo

Tracking Information
First Submitted Date  ICMJE October 17, 2019
First Posted Date  ICMJE October 30, 2019
Last Update Posted Date May 16, 2024
Actual Study Start Date  ICMJE November 3, 2019
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2023)
  • 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 ifinatamab deruxtecan (I-DXd) [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
Original 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) ]
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 Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Official Title  ICMJE Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-Pantumor01)
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 ifinatamab deruxtecan (I-DXd).
  • Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd 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: Ifinatamab deruxtecan (I-DXd)
A total anti-B7H3 antibody and MAAA-1181a
Study Arms  ICMJE
  • Experimental: Dose escalation
    Participants with advanced solid tumors who received I-DXd IV Q3W monotherapy during dose escalation phase. Enrollment to this phase is currently closed.
    Intervention: Drug: Ifinatamab deruxtecan (I-DXd)
  • Experimental: Dose expansion
    Currently enrolling participants with advanced solid tumors who will receive I-DXd IV Q3W monotherapy at the recommended dose for expansion.
    Intervention: Drug: Ifinatamab deruxtecan (I-DXd)
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: January 11, 2024)		 250
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2019)		 160
Estimated Study Completion Date  ICMJE March 1, 2027
Estimated Primary Completion Date December 1, 2024   (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 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator
  • 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, including I-DXd.
  • Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.
  • 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.
  • Uncontrolled significant cardiovascular disease
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement, prior pneumonectomy, or requirement for supplemental oxygen
  • Has an uncontrolled infection requiring systemic therapy.
  • 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) 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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Current Responsible Party Daiichi Sankyo
Original Responsible Party Daiichi Sankyo Co., Ltd.
Current Study Sponsor  ICMJE Daiichi Sankyo
Original Study Sponsor  ICMJE Daiichi Sankyo Co., Ltd.
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE
Study Director: Global Clinical Leader Daiichi Sankyo
PRS Account Daiichi Sankyo
Verification Date May 2024

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