RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2019-11-03
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04145622

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  2. * 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
  3. * Has adequate cardiac, hematopoietic, renal and hepatic functions
  4. * Has an adequate treatment washout period prior to start of study treatment
  5. * 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.
  1. * Has prior treatment with B7-H3 targeted agent, including I-DXd.
  2. * 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.
  3. * 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.
  4. * Uncontrolled significant cardiovascular disease
  5. * 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
  6. * Has an uncontrolled infection requiring systemic therapy.
  7. * 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

Study Contact

(Japan sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
+81-3-6225-1111(M-F 9-5 JST)
dsclinicaltrial@daiichisankyo.co.jp
(US sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
908-992-6400
CTRinfo_us@daiichisankyo.com

Principal Investigator

Global Clinical Leader
STUDY_DIRECTOR
Daiichi Sankyo

Study Locations (Sites)

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
Saint 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

Collaborators and Investigators

Sponsor: Daiichi Sankyo

  • Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-03
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2019-11-03
Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

  • Advanced Solid Tumor
  • Malignant Tumor
  • Ifinatamab deruxtecan (I-DXd)

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Malignant Solid Tumor