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

Description

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.

Conditions

Advanced Solid Tumor, Malignant Solid Tumor

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States, 90048

Denver

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218

Orlando

Florida Cancer Specialists, Orlando, Florida, United States, 32804

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Hackensack

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

New York

Columbia University Medical Center, New York, New York, United States, 10032

New York

Memorial Sloan-Kettering Cancer Center, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Daiichi Sankyo,

Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

2027-03-01