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 (May 2026). This Phase 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; and cutaneous melanoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) low expression (IHC 2+/ISH- or IHC 1+ (ISH- or untested)) (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) negative for HER2 expression (IHC 0 (ISH- or untested)) (IHC 0 (ISH- or untested))
Negative for HER2 expression, defined as IHC 0 (ISH- or untested) according to ASCO-CAP 2018 HER2 testing guidelines
Required: CDKN2A microsatellite stable
unresectable or metastatic CRC with microsatellite stable status
Required: CDKN2A p16 status (documented for oropharyngeal cancer)
Documented p16 status for oropharyngeal cancer (historical results are acceptable if available)
Allowed: CDKN2A microsatellite instability-high or mismatch repair deficient
irrespective of microsatellite instability or mismatch repair status
Allowed: CDKN2A microsatellite instability-high or mismatch repair deficient
Subjects with PD-(L)1+ or MSI-H/dMMR should receive ICI treatment if ICIs are standard of care in the country, unless the subject is ineligible for ICI treatment.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — advanced/metastatic
disease progression on or after the previous standard-of-care regimen in the advanced/metastatic setting
Cannot have received: B7-H3-targeted agent (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 (ADC) with exatecan derivative (T-DXd)
Exception: if discontinued due to treatment-related toxicities
Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, T-DXd) due to treatment-related toxicities
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Los Angeles Cancer Network · Los Angeles, California
- Valkyrie Clinical Trials · 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 →
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