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RECRUITING
NCT04145622
PHASE1/PHASE2

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

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2019-11-03

Completion Date

2029-10-31

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DRUG

Ifinatamab deruxtecan (I-DXd)

A total anti-B7H3 antibody and MAAA-1181a

Locations (25)

Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Florida Cancer Specialists

Orlando, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Sidney Kimmel Cancer Center - Thomas Jefferson

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

MDACC (MD Anderson Cancer Center)

Houston, Texas, United States

Aichi Cancer Center Hospital

Aichi, Japan

National Cancer Center Hospital East

Chiba, Japan

Hokkaido University Hospital

Hokkaido, Japan

Osaka University Hospital

Osaka, Japan

Kindai University Hospital

Ōsaka-sayama, Japan

Saitama Cancer Center

Saitama, Japan

Shizuoka Cancer Center Hospital and Research Institute

Shizuoka, Japan

National Cancer Center Hospital

Tokyo, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

Showa University Hospital

Tokyo, Japan