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Study of Ifinatamab Deruxtecan (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 : January 16, 2024
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Malignant Solid Tumor Drug: Ifinatamab deruxtecan (I-DXd) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 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 : November 3, 2019
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : March 1, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose escalation
All participants enrolled in the dose escalation part
 Drug: Ifinatamab deruxtecan (I-DXd)
A total anti-B7H3 antibody and MAAA-1181a
Experimental: Dose expansion
All participants enrolled in the dose expansion part
 Drug: Ifinatamab deruxtecan (I-DXd)
A total anti-B7H3 antibody and MAAA-1181a


Outcome Measures
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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 ifinatamab deruxtecan (I-DXd) [ 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) ]

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:

  • 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. Castrate-resistant prostate cancer (CRPC) participants with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.
  • 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.
  • 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 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.
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): NCT04145622


Contacts
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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

Locations
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Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo
More Information
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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT04145622    
Other Study ID Numbers: DS7300-A-J101
194992 ( Other Identifier: JapicCTI )
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: January 16, 2024
Last Verified: January 2024
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 ( Daiichi Sankyo Co., Ltd. ):
Advanced Solid Tumor
Malignant Tumor
Ifinatamab deruxtecan (I-DXd)
Additional relevant MeSH terms:
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Neoplasms