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NCT04145622PHASE1, PHASE2Recruiting

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

Daiichi Sankyo

Start Date

11/3/2019

Completion Date

10/31/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Ifinatamab deruxtecan (I-DXd)

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Conditions

Advanced Solid TumorMalignant Solid Tumor

Locations

Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California 90048

United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado 80218

United States

Florida Cancer Specialists

Orlando, Florida 32804

United States

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02115

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Washington University

St Louis, Missouri 63110

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Columbia University Medical Center

New York, New York 10032

United States

Memorial Sloan-Kettering Cancer Center

New York, New York 10065

United States

The Ohio State University

Columbus, Ohio 43210

United States

Sidney Kimmel Cancer Center - Thomas Jefferson

Philadelphia, Pennsylvania 19107

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

MDACC (MD Anderson Cancer Center)

Houston, Texas 77030

United States

Aichi Cancer Center Hospital

Aichi, 464-8681

Japan

National Cancer Center Hospital East

Chiba, 277-8577

Japan

Hokkaido University Hospital

Hokkaido, 060-8648

Japan

Kobe City Medical Center General Hospital

Hyōgo, 650-0047

Japan

Kagawa University Hospital

Kagawa, 761-0793

Japan

The University of Osaka Hospital

Osaka, 565-0871

Japan

Kindai University Hospital

Ōsaka-sayama, 589-8511

Japan

Saitama Cancer Center

Saitama, 362-0806

Japan

Shizuoka Cancer Center

Shizuoka, 411-8777

Japan

National Cancer Center Hospital

Tokyo, 104-0045

Japan

Cancer Institute Hospital of JFCR

Tokyo, 135-8550

Japan

Showa Medical University Hospital

Tokyo, 142-8666

Japan

Keio University Hospital

Tokyo, 160-8582

Japan