RECRUITING

A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

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 study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma.

Official Title

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

Quick Facts

Study Start:2024-04-10
Study Completion:2028-07-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06330064

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. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

(US) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
9089926400
CTRinfo@dsi.com
(Asia) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
+81-3-6225-1111 (M-F 9-5 JST
dsclinicaltrial@daiichisankyo.co.jp

Study Locations (Sites)

Los Angeles Cancer Network
Los Angeles, California, 90017
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
Pih Health Hematology Medical Oncology
Whittier, California, 90602
United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
United States
Regents of the University of Minnesota
Minneapolis, Minnesota, 55455
United States
New York University Medical Center Prime
New York, New York, 10016
United States
Icahn School of Medicine At Mount Sinai Prime
New York, New York, 10029
United States
Clinical Research Alliance
Westbury, New York, 11590
United States
Tn Gynecologic Oncology Group, Llc
Chattanooga, Tennessee, 37403
United States
The West Clinic
Germantown, Tennessee, 38138
United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, 84108
United States
Wenatchee Hospitals and Clinics
Wenatchee, Washington, 98801
United States

Collaborators and Investigators

Sponsor: 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 Date2024-04-10
Study Completion Date2028-07-25

Study Record Updates

Study Start Date2024-04-10
Study Completion Date2028-07-25

Terms related to this study

Keywords Provided by Researchers

  • Recurrent or metastatic solid tumors
  • Endometrial cancer
  • Head and neck squamous cell carcinoma
  • Colorectal cancer
  • Hepatocellular carcinoma
  • Adenocarcinoma of esophagus, gastroesophageal junction, and stomach
  • Urothelial carcinoma
  • Ovarian cancer
  • Cervical cancer
  • Biliary tract cancer
  • Human epidermal growth factor 2 (HER2)-low breast cancer
  • HER2 immunohistochemistry 0 breast cancer
  • Cutaneous melanoma
  • Pancreatic ductal adenocarcinoma
  • Ifinatamab deruxtecan (I-DXD)
  • DS7300a

Additional Relevant MeSH Terms

  • Recurrent or Metastatic Solid Tumors