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A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 2
Started2024-02-26
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
Study Status, Contacts/Locations v21
Trial sites expanded: 91 → 94 locations
2026-08-26
Study Status, Contacts/Locations v20
Trial sites expanded: 86 → 89 locations
2026-08-19
Study Status, Contacts/Locations v19
Study sites85→86
2026-08-06
Study Status, Contacts/Locations v18
Study sitesdetails revised at 3 of 85 sites
2026-05-12
Study Status, Contacts/Locations v17
Study sites84→85
Show 16 earlier versions
2026-01-26
Study Status, Contacts/Locations v16
Study sites80→84
2025-10-09
Study Status, Contacts/Locations v15
Study sites78→80
2025-09-29
Study Status, Contacts/Locations v14
Study sites77→78
2025-09-03
Study Status, Contacts/Locations v13
Study sites75→77
2025-08-12
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v12
Primary completion date2025-06-30→2027-09-01
Completion date2026-04-30→2028-10-10
Enrollment target400→740
Study sites63→75
Eligibility criteria+2,232 characters
[...] disease settings will be counted as 1 line of prior therapy A minimum of 20 subjectsParticipants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination willcan be enrolled. Esophageal Carcinoma Pathologically or cytolog [...] d ≥1 cytotoxic chemotherapy regimen that included a taxane. Gastric Cancer 2L Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0/1+ or IHC 2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines an [...] [...]
Secondary endpoints15 to 16 entries
Correlation Between HER3 Protein Expression and Efficacy
Study description+39 characters
[...] Xd monotherapy in subjects with refractory locally advanced unresectable or metastatic solid tumors who have been previously treated [...] DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. Secondary objectives include the assess [...] DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. HER3 protein expression in tumor tissue [...]
2025-06-13
Study Status, Contacts/Locations v11
Study sites62→63
2025-05-28
Study Status, Contacts/Locations v10
Study sites61→62
2025-05-12
Study Status, Contacts/Locations v9
Study sites60→61
2025-04-17
Study Status, Contacts/Locations v8
Study sites57→60
2025-03-25
Study Status, Contacts/Locations v7
Study sites56→57
2025-03-10
Study Status, Contacts/Locations v6
Study sites54→56
2025-02-20
Study Status, Contacts/Locations v5
Study sites52→54
2025-01-24
Study Status, Contacts/Locations v4
Study sites10→52
2024-05-30
Study Status, Study Description, Eligibility, Contacts/Locations v3
Study sites3→10
Eligibility criteria-9 characters
[...] tive or negative (as determined by local standard). Excludes primary tumor location in the nasopharynx, nasal cavity, paranasal [...]
2024-05-15
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Enrollment target120→400
Study sites1→3
Eligibility criteria+4,847 characters
[...] all subjects to meet the baseline tumor tissue requirement. Is a male or femaleParticipants aged ≥18 years (follow local regulatory requirements if the [...] (not curable by surgery or radiation) as follows: Cutaneous or(acral and non-acral) melanoma Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors [ICIs] [ie, anti-CTLA4, anti- LAG-3] i [...] [...]
Secondary endpoints11 to 15 entries
Overall Number of Participants With Treatment-emergent Adverse Events Following HER3-DXd Monotherapy (All Cohorts) Duration of Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) Clinical Benefit Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) Disease Control Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) Time to Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer [...] [...]
Primary endpoints1 to 2 entries
Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) Proportion of Participants Achieving a ≥50% Decrease in PSA (Prostate Cancer Cohort Only)
2024-03-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01-28→confirmed 2024-02-26
Study sites0→1
2023-12-07
Original filing
Daiichi Sankyo
69 trials monitored
See 8 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
Lung Cancer
4,033 trials monitored
See 210 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,914 trials monitored
See 156 trials at risk
and 10 more diseases
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.
Trial Details
NCT Number NCT06172478
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer, Ovarian Carcinoma, Cervical Cancer, Endometrial Cancer, Bladder Cancer +6 more
Enrollment 740 participants
Start Date 2024-02-26
Primary Completion 2027-09-01 (estimated)
Study Completion 2028-10-10 (estimated)
Updated on ClinicalTrials.gov 2026-10-01