A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Daiichi Sankyo
- Study ID
- NCT06330064
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Recurrent or Metastatic Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ifinatamab deruxtecan — DRUGIntravenous administration
Study Details
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; cutaneous melanoma; and neuroendocrine carcinoma (NEC).
Key Dates
- First listed
- Mar 26, 2024
- Start date
- Apr 10, 2024
- Status verified
- Aug 2026
- Primary completion
- Jul 25, 2028
- Completion
- Jul 25, 2028
Study Design
- Enrollment
- 680 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1: Endometrial Cancer (EC)Participants with recurrent or metastatic EC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 milligrams per kilogram (mg/kg), intravenous (IV) infusion.
- Experimental: Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC)Participants with recurrent or metastatic HNSCC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 3: Pancreatic Ductal Adenocarcinoma (PDAC)Participants with recurrent or metastatic PDAC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 4: Colorectal Cancer (CRC)Participants with recurrent or metastatic CRC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 5: Hepatocellular Carcinoma (HCC)Participants with recurrent or metastatic HCC who were previously treated with 1 or more systemic therapy will receive I-DXd, at the determined dose.
- Experimental: Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric)Participants with recurrent or metastatic Ad-Eso/GEJ/gastric who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 7: Urothelial Carcinoma (UC)Participants with recurrent or metastatic UC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 8: Ovarian Cancer (OVC)Participants with recurrent or metastatic non-squamous OVC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 9: Cervical Cancer (CC)Participants with recurrent or metastatic CC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 10: Biliary Tract Cancer (BTC)Participants with recurrent or metastatic BTC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancer (BC)Participants with recurrent or metastatic human epidermal growth factor 2 (HER2)-low BC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 12: HER2 Immunohistochemistry (IHC) 0 BCParticipants with recurrent or metastatic HER2 IHC 0 BC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 13: Cutaneous MelanomaParticipants with recurrent or metastatic cutaneous melanoma who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.
- Experimental: Cohort 14: Neuroendocrine Carcinoma (NEC)Participants with recurrent or metastatic NEC who were previously treated with 1 or more systemic therapy or for whom the standard therapy is not considered appropriate by the investigator will receive I-DXd, 12 mg/kg, IV infusion.
Primary Outcome Measure
Objective Response Rate (ORR) as Assessed by Investigator [ Time Frame: From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first (up to approximately 60 months) ]
Central Contacts
- (US) Daiichi Sankyo Contact for Clinical Trial Information9089926400
- (Asia) Daiichi Sankyo Contact for Clinical Trial Information+81-3-6225-1111 (M-F 9-5 JST
Locations (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Los Angeles Cancer Network | Los Angeles | California | 91204 | Principal Investigator |
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | - |
| Pih Health Hematology Medical Oncology | Whittier | California | 90602 | Principal Investigator |
| Orchard Healthcare Research Inc | Skokie | Illinois | 60077 | Principal Investigator |
| M Health Fairview University of Minnesota Medical Center | Minneapolis | Minnesota | 55114 | Principal Investigator |
| Icahn School of Medicine At Mount Sinai Prime | New York | New York | 10029 | Principal Investigator |
| NYU Langone Health | New York | New York | 10016 | Principal Investigator |
| Clinical Research Alliance, Inc | Westbury | New York | 11590 | Principal Investigator |
| White Plains Hospital | White Plains | New York | 10601 | Principal Investigator |
| Erlanger Health, Inc | Chattanooga | Tennessee | 37403 | Principal Investigator |
| The West Clinic | Germantown | Tennessee | 38138 | Principal Investigator |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | - |
| Texas Oncology - West Texas | Amarillo | Texas | 79124 | - |
| Texas Oncology, P.A. | Dallas | Texas | 75246 | - |
| Texas Oncology Gulf Coast | Pearland | Texas | 77584 | - |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | Principal Investigator |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Principal Investigator |
| Wenatchee Valley Hospital and Clinics | Wenatchee | Washington | 98801 | Principal Investigator |
Find similar trials in Los Angeles, CA
By research site
Los Angeles Cancer Network· Los Angeles, CAValkyrie Clinical Trials· Los Angeles, CAPih Health Hematology Medical Oncology· Whittier, CAOrchard Healthcare Research Inc· Skokie, ILM Health Fairview University of Minnesota Medical Center· Minneapolis, MNIcahn School of Medicine At Mount Sinai Prime· New York, NY
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