Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

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)

This is a single group study 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor; Malignant Solid Tumor
• Intervention / Treatment: Drug: Ifinatamab deruxtecan (I-DXd)

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: (Japan sites) Daiichi Sankyo Contact for Clinical Trial Information; Phone Number: +81-3-6225-1111(M-F 9-5 JST); Email: dsclinicaltrial@daiichisankyo.co.jp
• Study Contact Backup: Name: (US sites) Daiichi Sankyo Contact for Clinical Trial Information; Phone Number: 908-992-6400; Email: CTRinfo_us@daiichisankyo.com

Study Locations

• Japan
  • Aichi, Japan, 464-8681
    • Recruiting
    • Aichi Cancer Center Hospital
    • Contact: See Central Contact
  • Chiba, Japan, 277-8577
    • Recruiting
    • National Cancer Center Hospital East
    • Contact: See Central Contact
  • Hokkaido, Japan, 060-8648
    • Recruiting
    • Hokkaido University Hospital
    • Contact: See Central Contact
  • Hyōgo, Japan, 650-0047
    • Recruiting
    • Kobe City Medical Center General Hospital
  • Kagawa, Japan, 761-0793
    • Recruiting
    • Kagawa University Hospital
  • Osaka, Japan, 565-0871
    • Recruiting
    • The University of Osaka Hospital
    • Contact: See Central Contact
  • Saitama, Japan, 362-0806
    • Recruiting
    • Saitama Cancer Center
    • Contact: See Central Contact
  • Shizuoka, Japan, 411-8777
    • Recruiting
    • Shizuoka Cancer Center
    • Contact: See Central Contact
  • Tokyo, Japan, 104-0045
    • Recruiting
    • National Cancer Center Hospital
    • Contact: See Central Contact
  • Tokyo, Japan, 160-8582
    • Recruiting
    • Keio University Hospital
  • Tokyo, Japan, 135-8550
    • Recruiting
    • Cancer Institute Hospital Of JFCR
    • Contact: See Central Contact
  • Tokyo, Japan, 142-8666
    • Recruiting
    • Showa Medical University Hospital
    • Contact: See Central Contact
  • Ōsaka-sayama, Japan, 589-8511
    • Recruiting
    • Kindai University Hospital
    • Contact: See Central Contact
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Withdrawn
      • Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Sarah Cannon Research Institute at HealthONE
      • Contact: Site Coordinator
  • Florida
    • Orlando, Florida, United States, 32804
      • Withdrawn
      • Florida Cancer Specialists
    • Sarasota, Florida, United States, 34232
      • Recruiting
      • Florida Cancer Specialists
      • Contact: Site Coordinator
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Active, not recruiting
      • Dana Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Active, not recruiting
      • Henry Ford Hospital
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • John Theurer Cancer Center at Hackensack University Medical Center
      • Contact: Site Coordinator
  • New York
    • New York, New York, United States, 10032
      • Withdrawn
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Active, not recruiting
      • Memorial Sloan-Kettering Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Withdrawn
      • The Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Withdrawn
      • Sidney Kimmel Cancer Center - Thomas Jefferson
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Active, not recruiting
      • Tennessee Oncology
    • Nashville, Tennessee, United States, 37203
      • Active, not recruiting
      • SCRI Oncology Partners
  • Texas
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • MDACC (MD Anderson Cancer Center)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

For Expansion Cohort 4 2L ESCC participants only:

• Has disease progression a post platinum-based and an immune checkpoint inhibitor (ICI) treatment per global or local guidelines, with a maximum of one prior line of systemic therapy for unresectable advanced or metastatic ESCC.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Ifinatamab deruxtecan (I-DXd); A total anti-B7H3 antibody and MAAA-1181a; Other Names: DS-7300a; 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.	Drug: Ifinatamab deruxtecan (I-DXd); A total anti-B7H3 antibody and MAAA-1181a; Other Names: DS-7300a; I-DXd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the incidence of dose-limiting toxicities (DLTs)	Day 1 to Day 21 in Cycle 1 in the dose escalation part
Evaluate the incidence of adverse events (AEs)	Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd)	Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterize the PK parameter AUClast	Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter AUCtau	Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter Cmax	Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter Tmax	Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Characterize the PK parameter Ctrough	Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Assess the incidence of anti-drug antibodies (ADAs)	Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo

Publications and helpful links

General Publications

• Johnson ML, Patel MR, Falchook GS, Koyama T, Gutierrez M, Awad MM, Piha-Paul SA, Friedman CF, Satoh T, Okamoto N, Singh J, Yoshizuka N, Windish HP, Qian M, Tran BP, Doi T. Ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate, in patients with advanced solid tumours (IDeate-PanTumor01): dose-escalation results from a phase 1/2 trial. Lancet Oncol. 2026 Apr;27(4):491-501. doi: 10.1016/S1470-2045(25)00733-8.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2019
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Solid Tumor; Malignant Tumor; Ifinatamab deruxtecan (I-DXd)
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: DS7300-A-J101; 194992 (Other Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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/
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No