OncoMatch/Clinical Trials/NCT06330064
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Is NCT06330064 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies Ifinatamab deruxtecan for recurrent or metastatic solid tumors.
Treatment: Ifinatamab deruxtecan — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) expression (IHC 2+/ISH- or IHC 1+ (ISH- or untested))
Low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested), according to ASCO-CAP 2018 HER2 testing guidelines
Required: HER2 (ERBB2) wild-type (IHC 0 (ISH- or untested))
Negative for HER2 expression, defined as IHC 0 (ISH- or untested) according to ASCO-CAP 2018 HER2 testing guidelines
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: B7-H3-targeted therapy (orlotamab, enoblituzumab, I-DXd)
Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd
Cannot have received: antibody drug conjugate with exatecan derivative (T-DXd)
Exception: discontinuation due to treatment-related toxicities
Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., T-DXd) due to treatment-related toxicities
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Valkyrie Clinical Trials · Los Angeles, California
- Los Angeles Cancer Network · Los Angeles, California
- Pih Health Hematology Medical Oncology · Whittier, California
- Orchard Healthcare Research Inc · Skokie, Illinois
- M Health Fairview University of Minnesota Medical Center · Minneapolis, Minnesota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06330064 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior B7-H3-targeted therapy, antibody drug conjugate with exatecan derivative disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify