OncoMatch/Clinical Trials/NCT06172478
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Is NCT06172478 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies HER3-DXd for advanced solid tumor.
Treatment: HER3-DXd — This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \[cutaneous/acral\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Melanoma
Head and Neck Squamous Cell Carcinoma
Gastric Cancer
Ovarian Cancer
Cervical Cancer
Endometrial Cancer
Urothelial Carcinoma
Esophageal Carcinoma
Pancreatic Cancer
Prostate Cancer
Non-Small Cell Lung Carcinoma
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative expression (IHC 0/1+ or IHC 2+/ISH-) (IHC 0/1+ or IHC 2+/ISH-)
gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0/1+ or IHC 2+/in situ hybridization negative)
Required: HER2 (ERBB2) negative expression (IHC 0/1+ or IHC 2+/ISH-) (IHC 0/1+ or IHC 2+/ISH-)
gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0/1+ or IHC 2+/in situ hybridization negative)
Required: HER2 (ERBB2) negative expression (IHC2+/ISH-, IHC1+, or IHC0) (IHC2+/ISH-, IHC1+, or IHC0)
breast cancer that is assessed as HER2 negative (IHC2+/ISH-, IHC1+, or IHC0 per ASCO/CAP guidelines)
Required: ALK wild-type
absence of actionable driver mutation (ie, ALK rearrangement)
Required: BRAF wild-type
absence of actionable driver mutation (ie, BRAF V600E mutation)
Required: EGFR wild-type
absence of actionable driver mutation (ie, EGFR-activating mutations [exon 19 deletion or L858R mutation], EGFR exon 20 insertion mutation)
Required: HER2 (ERBB2) wild-type
absence of actionable driver mutation (ie, HER2 mutation)
Required: KRAS wild-type
absence of actionable driver mutation (ie, KRAS G12C mutation)
Required: MET wild-type
absence of actionable driver mutation (ie, MET exon 14 skipping mutation)
Required: NTRK1 wild-type
absence of actionable driver mutation (ie, NTRK 1/2/3 gene fusion)
Required: NTRK2 wild-type
absence of actionable driver mutation (ie, NTRK 1/2/3 gene fusion)
Required: NTRK3 wild-type
absence of actionable driver mutation (ie, NTRK 1/2/3 gene fusion)
Required: RET wild-type
absence of actionable driver mutation (ie, RET rearrangement)
Required: ROS1 wild-type
absence of actionable driver mutation (ie, ROS1 rearrangement)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-HER3 antibody and/or ADC with exatecan derivative topoisomerase I inhibitor (trastuzumab deruxtecan)
prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan)
Cannot have received: topoisomerase-1 inhibitor (irinotecan)
previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- Yale Cancer Center · New Haven, Connecticut
- AdventHealth Medical Group Oncology Research at Celebration · Kissimmee, Florida
- University of Illinois Cancer Center · Chicago, Illinois
- Johns Hopkins University · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06172478 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-HER3 antibody and/or ADC with exatecan derivative topoisomerase I inhibitor, topoisomerase-1 inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative expression (IHC 0/1+ or IHC 2+/ISH-) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative expression (IHC 0/1+ or IHC 2+/ISH-) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative expression (IHC2+/ISH-, IHC1+, or IHC0) 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