A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT06172478
Last Updated: 2026-01-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
740 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-02-26
Study Completion Date
2028-10-10
Brief Summary
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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.
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Detailed Description
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This study is designed to assess the safety and efficacy of HER3-DXd monotherapy in subjects with refractory locally advanced unresectable or metastatic solid tumors who have been previously treated with ≥1 prior line of systemic anticancer therapy.
The primary objective of the study is to assess the efficacy of HER3-DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. Secondary objectives include the assessment of safety and tolerability, efficacy, and pharmacokinetics of HER3-DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. HER3 protein expression in tumor tissue and its relationship with HER3-DXd efficacy will also be evaluated.
The primary objective of the study is to assess the efficacy of HER3-DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. Secondary objectives include the assessment of safety and tolerability, efficacy, and pharmacokinetics of HER3-DXd monotherapy for each type of indicated locally advanced unresectable or metastatic tumor. HER3 protein expression in tumor tissue and its relationship with HER3-DXd efficacy will also be evaluated.
Conditions
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Advanced Solid Tumor
Melanoma
Head and Neck Cancer
Gastric Cancer
Ovarian Carcinoma
Cervical Cancer
Endometrial Cancer
Bladder Cancer
Esophageal Cancer
Pancreatic Carcinoma
Prostate Cancer
Non-small Cell Lung Cancer (NSCLC)
Lung Cancer
Breast Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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HER3-DXd Monotherapy
Participants with locally advanced unresectable or metastatic cancer (melanoma, head and neck, 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) will receive an intravenous infusion of HER3-DXd monotherapy 5.6 mg/kg every 3 weeks (Q3W).
Group Type
EXPERIMENTAL
HER3-DXd
Intervention Type
DRUG
Intravenous infusion 5.6 mg/kg administered Q3W on Day 1 of each 21-day cycle
Interventions
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HER3-DXd
Intravenous infusion 5.6 mg/kg administered Q3W on Day 1 of each 21-day cycle
Intervention Type
DRUG
Other Intervention Names
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Patritumab Deruxtecan
U3-1402
Eligibility Criteria
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Inclusion Criteria
Participants must meet all of the following criteria to be eligible for enrollment into the study:
1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.
2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old).
3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:
Cutaneous (acral and non-acral) melanoma
1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma
2. 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 \[ICIs\] \[ie, anti-CTLA4, anti- LAG-3\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF/MEK inhibitor therapy as well.
Squamous cell carcinomas of the head and neck
3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.
4. Disease progression after having received treatment with ≥1 and \<3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.
Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.
Gastric or GEJ adenocarcinoma
5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \[IHC\] 0/1+ or IHC 2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.
6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.
Ovarian Carcinoma
7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
8. Documented disease progression ≥4 weeks after the last dose of PBC and \<6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.
Cervical Cancer
9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.
10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and/or tissue factor directed ADC (tisotumab vedotin \[TV\]) per regional standard of care.
Endometrial Cancer
11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.
12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced/metastatic setting.
Bladder Cancer
13. Pathologically or cytologically documented locally advanced/unresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell/neuroendocrine tumors are not allowed even if mixed histology.
14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.
* Required treatments can be given in combination or sequentially
* Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy
* The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy
* Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.
Esophageal Carcinoma
15. Pathologically or cytologically documented esophageal squamous cell carcinoma.
16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced/metastatic setting.
Pancreatic Carcinoma
17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.
18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced/metastatic setting.
Prostate Cancer
19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).
20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
21. Surgically or medically castrated, with testosterone levels of \<50 ng/dL.
22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.
23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.
24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.
Gastric Cancer 2L
25. 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 and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.
26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.
Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \[exon 19 deletion or L858R mutation\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1/2/3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.
cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.
Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+/ISH-, IHC1+, or IHC0 per ASCO/CAP guidelines), and HR positive (either ER and/or PgR positive \[ER or PgR ≥1%\] per ASCO/CAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.
ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4/6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.
4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.
5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:
1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).
OR
2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)
6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.
1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.
2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old).
3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:
Cutaneous (acral and non-acral) melanoma
1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma
2. 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 \[ICIs\] \[ie, anti-CTLA4, anti- LAG-3\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF/MEK inhibitor therapy as well.
Squamous cell carcinomas of the head and neck
3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.
4. Disease progression after having received treatment with ≥1 and \<3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.
Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.
Gastric or GEJ adenocarcinoma
5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \[IHC\] 0/1+ or IHC 2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.
6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.
Ovarian Carcinoma
7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
8. Documented disease progression ≥4 weeks after the last dose of PBC and \<6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.
Cervical Cancer
9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.
10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and/or tissue factor directed ADC (tisotumab vedotin \[TV\]) per regional standard of care.
Endometrial Cancer
11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.
12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced/metastatic setting.
Bladder Cancer
13. Pathologically or cytologically documented locally advanced/unresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell/neuroendocrine tumors are not allowed even if mixed histology.
14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.
* Required treatments can be given in combination or sequentially
* Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy
* The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy
* Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.
Esophageal Carcinoma
15. Pathologically or cytologically documented esophageal squamous cell carcinoma.
16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced/metastatic setting.
Pancreatic Carcinoma
17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.
18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced/metastatic setting.
Prostate Cancer
19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).
20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
21. Surgically or medically castrated, with testosterone levels of \<50 ng/dL.
22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.
23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.
24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.
Gastric Cancer 2L
25. 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 and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.
26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.
Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \[exon 19 deletion or L858R mutation\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1/2/3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.
cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.
Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+/ISH-, IHC1+, or IHC0 per ASCO/CAP guidelines), and HR positive (either ER and/or PgR positive \[ER or PgR ≥1%\] per ASCO/CAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.
ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4/6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.
4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.
5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:
1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).
OR
2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)
6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.
Exclusion Criteria
Participants who meet any of the following criteria will be disqualified from entering the study:
1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.
2. Has nasopharyngeal cancer.
3. Has mucosal or uveal melanoma.
4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
6. Is receiving chronic systemic corticosteroids dosed at \>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.
Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.
7. Had 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).
8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:
1. Adequately treated nonmelanoma skin cancer
2. Adequately treated intraepithelial carcinoma of the cervix
3. Any other curatively treated in situ disease
9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness/social situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol
10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.
1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.
2. Has nasopharyngeal cancer.
3. Has mucosal or uveal melanoma.
4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
6. Is receiving chronic systemic corticosteroids dosed at \>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.
Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.
7. Had 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).
8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:
1. Adequately treated nonmelanoma skin cancer
2. Adequately treated intraepithelial carcinoma of the cervix
3. Any other curatively treated in situ disease
9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness/social situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol
10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Sponsor Role
collaborator
Daiichi Sankyo
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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City of Hope
Duarte, California, United States
Site Status
RECRUITING
Yale Cancer Center
New Haven, Connecticut, United States
Site Status
RECRUITING
AdventHealth Medical Group Oncology Research at Celebration
Kissimmee, Florida, United States
Site Status
RECRUITING
University of Illinois Cancer Center
Chicago, Illinois, United States
Site Status
RECRUITING
Johns Hopkins University
Baltimore, Maryland, United States
Site Status
RECRUITING
Health Partners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
Site Status
RECRUITING
Health Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States
Site Status
RECRUITING
Washington University, School of Medicine
St Louis, Missouri, United States
Site Status
RECRUITING
Roswell Park Cancer Institute IDS
Buffalo, New York, United States
Site Status
RECRUITING
Memorial Sloan Kettering Hospital
New York, New York, United States
Site Status
RECRUITING
SCRI Oncology Partners
Nashville, Tennessee, United States
Site Status
RECRUITING
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Site Status
RECRUITING
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Site Status
RECRUITING
Chris O'Brien Lifehouse
Camperdown, , Australia
Site Status
RECRUITING
Icon Cancer Centre Chermside
Chermside, , Australia
Site Status
RECRUITING
Monash Medical Centre Clayton
Clayton, , Australia
Site Status
RECRUITING
Icon Cancer Centre Hobart
Hobart, , Australia
Site Status
RECRUITING
Icon Cancer Centre Townsville
Hyde Park, , Australia
Site Status
RECRUITING
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Site Status
RECRUITING
UZA
Edegem, , Belgium
Site Status
RECRUITING
Universitair Ziekenhuis Gent
Ghent, , Belgium
Site Status
RECRUITING
Universitair Ziekenhuis Brussel
Jette, , Belgium
Site Status
RECRUITING
UZ Leuven
Leuven, , Belgium
Site Status
RECRUITING
Cross Cancer Institute
Edmonton, Alberta, Canada
Site Status
RECRUITING
Sunnybrook Research Institute
Toronto, , Canada
Site Status
RECRUITING
Princess Margaret Cancer Centre
Toronto, , Canada
Site Status
RECRUITING
BC Cancer - Vancouver
Vancouver, , Canada
Site Status
RECRUITING
Sun Yat-sen University Cancer Center
Guangzhou, , China
Site Status
RECRUITING
Chu Bordeaux
Bordeaux, , France
Site Status
RECRUITING
Centre Georges Franăois Leclerc
Dijon, , France
Site Status
RECRUITING
Hopital Claude Huriez - Chu Lille
Lille, , France
Site Status
RECRUITING
Centre Léon Bérard
Lyon, , France
Site Status
RECRUITING
Hăpital de La Timone
Marseille, , France
Site Status
RECRUITING
Chu Nantes - Hătel Dieu
Nantes, , France
Site Status
RECRUITING
Institut Claudius Regaud
Toulouse, , France
Site Status
RECRUITING
ICL - Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Site Status
RECRUITING
Institut Gustave Roussy
Villejuif, , France
Site Status
RECRUITING
Krankenhaus Nordwest GmbH
Frankfurt, , Germany
Site Status
RECRUITING
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, , Hungary
Site Status
RECRUITING
Humanitas Gavazzeni
Bergamo, , Italy
Site Status
RECRUITING
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Site Status
RECRUITING
AOU Federico II - Oncologia Clinica
Napoli, , Italy
Site Status
RECRUITING
Centro Ricerche Cliniche di Verona s.r.l.
Verona, , Italy
Site Status
RECRUITING
Saitama Medical University International Medical Center
Hidaka, , Japan
Site Status
RECRUITING
National Cancer Center Hospital East
Kashiwa-shi, , Japan
Site Status
RECRUITING
NHO Shikoku Cancer Center
Matsuyama, , Japan
Site Status
RECRUITING
Shizuoka Cancer Center
Nagaizumi-cho, , Japan
Site Status
RECRUITING
Aichi Cancer Center Hospital
Nagoya, , Japan
Site Status
RECRUITING
Kindai University Hospital
Osakasayama-shi, , Japan
Site Status
RECRUITING
National Cancer Center Hospital
Tokyo, , Japan
Site Status
RECRUITING
Cancer Institute Hospital of JFCR
Tokyo, , Japan
Site Status
RECRUITING
Yokohama City University Medical Center
Yokohama, , Japan
Site Status
RECRUITING
Amsterdam UMC locatie Vumc
Amsterdam, , Netherlands
Site Status
RECRUITING
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Site Status
RECRUITING
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Site Status
RECRUITING
Maastricht University Medical Center
Maastricht, , Netherlands
Site Status
RECRUITING
Radboud University Medical Center
Nijmegen, , Netherlands
Site Status
RECRUITING
Akershus universitetssykehus
Lørenskog, , Norway
Site Status
RECRUITING
Haukeland universitetssjukehus
Lørenskog, , Norway
Site Status
RECRUITING
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, , Norway
Site Status
RECRUITING
Cha Bundang Medical Center, Cha University
Seongnam, , South Korea
Site Status
RECRUITING
Seoul National University Bundang Hospital
Seongnam, , South Korea
Site Status
RECRUITING
Seoul National University Hospital
Seoul, , South Korea
Site Status
RECRUITING
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Site Status
RECRUITING
Asan Medical Center
Seoul, , South Korea
Site Status
RECRUITING
Samsung Medical Center
Seoul, , South Korea
Site Status
RECRUITING
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Site Status
RECRUITING
Hospital Clinic de Barcelona
Barcelona, , Spain
Site Status
RECRUITING
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Site Status
RECRUITING
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Site Status
RECRUITING
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Site Status
RECRUITING
Hospital Universitario 12 de Octubre
Madrid, , Spain
Site Status
RECRUITING
HOSPITAL REGIONAL UNIVERSITARIO de MALAGA AVDA.
Málaga, , Spain
Site Status
RECRUITING
Hospital Universitario Virgen Macarena
Seville, , Spain
Site Status
RECRUITING
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Site Status
RECRUITING
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Site Status
RECRUITING
National Cheng Kung University Hospital
Tainan, , Taiwan
Site Status
RECRUITING
National Taiwan University Hospital
Taipei, , Taiwan
Site Status
RECRUITING
Taipei Veterans General Hospital
Taipei, , Taiwan
Site Status
RECRUITING
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Site Status
RECRUITING
University Hospital Coventry
Coventry, , United Kingdom
Site Status
RECRUITING
Barts Hospital
London, , United Kingdom
Site Status
RECRUITING
Royal Free Hospital
London, , United Kingdom
Site Status
RECRUITING
Nottingham City Hospital Campus
Nottingham, , United Kingdom
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Australia
Belgium
Canada
China
France
Germany
Hungary
Italy
Japan
Netherlands
Norway
South Korea
Spain
Taiwan
United Kingdom
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Principal Investigator
Role: primary
Principal Investigator
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
See Central Contact
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Powles T, Bhatia A, Burtness B, Kogawa T, Nishina T, Nakayama I, Fountzilas C, Castillo DR, McKean M, Meric-Bernstam F, Colombo N, Smithy JW, Fayette J, Chandra S, Sternberg DW, Jin F, Sullivan K, Yueh S, Clinthorne G, Aguilo AE, Kudchadkar R, Hayashi H. HERTHENA-PanTumor01: a phase II study of patritumab deruxtecan (HER3-DXd) in previously treated advanced solid tumors. Future Oncol. 2025 Oct;21(25):3283-3292. doi: 10.1080/14796694.2025.2561539. Epub 2025 Oct 14.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-507641-29-00
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031230575
Identifier Type: OTHER
Identifier Source: secondary_id
U31402-277
Identifier Type: -
Identifier Source: org_study_id
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