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

Conditions

• Recurrent or Metastatic Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ifinatamab deruxtecan — DRUG
  Intravenous 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; and cutaneous melanoma.

Key Dates

Start date

Apr 10, 2024

Status verified

Feb 2026

Primary completion

Jul 25, 2028

Completion

Jul 25, 2028

Study Design

Enrollment

520 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Endometrial Cancer
  Participants with recurrent or metastatic endometrial cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 2: Head and Neck Squamous Cell Carcinoma
  Participants with recurrent or metastatic head and neck squamous carcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 3: Pancreatic Ductal Adenocarcinoma
  Participants with recurrent or metastatic pancreatic ductal adenocarcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 4: Colorectal Cancer
  Participants with recurrent or metastatic colorectal cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 5: Hepatocellular Carcinoma
  Participants with recurrent or metastatic hepatocellular carcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd at the determined dose.
• Experimental: Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomach
  Participants with recurrent or metastatic adenocarcinoma of esophagus, gastroesophageal junction, and stomach who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 7: Urothelial carcinoma
  Participants with recurrent or metastatic urothelial carcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 8: Ovarian cancer
  Participants with recurrent or metastatic non-squamous ovarian cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 9: Cervical cancer
  Participants with recurrent or metastatic cervical cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 10: Biliary tract cancer
  Participants with recurrent or metastatic biliary tract cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancer
  Participants with recurrent or metastatic human epidermal growth factor 2 (HER2)-low breast cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 12: HER2 immunohistochemistry (IHC) 0 breast cancer
  Participants with recurrent or metastatic HER2 immunohistochemistry (IHC) 0 breast cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
• Experimental: Cohort 13: Cutaneous melanoma
  Participants with recurrent or metastatic cutaneous melanoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.

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 57 months ]

Central Contacts

• (US) Daiichi Sankyo Contact for Clinical Trial Information
  9089926400
  [email protected]
• (Asia) Daiichi Sankyo Contact for Clinical Trial Information
  +81-3-6225-1111 (M-F 9-5 JST
  [email protected]

Locations (17)

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