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Advanced Solid TumorPhase 2NCT06172478

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

A Phase 2 study testing HER3-DXd in people with Advanced Solid Tumor and Melanoma, run by Daiichi Sankyo at 96 sites in 16 countries.

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Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HER3-DXd
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
740 participants
Where
96 sitesin 16 countries
Study dates
26 Feb 2024to 10 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria to be eligible for enrollment into the study:
  • 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.
  • Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
  • Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:
  • Cutaneous (acral and non-acral) melanoma
  • Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma
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  • 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
  • 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.
  • 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
  • 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.
  • Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.
  • Ovarian Carcinoma
  • Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  • 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
  • Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.
  • 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
  • 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.
  • 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
  • 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.
  • 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
  • Pathologically or cytologically documented esophageal squamous cell carcinoma.
  • 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
  • Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.
  • Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced/metastatic setting.
  • Prostate Cancer
  • Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).
  • Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
  • Surgically or medically castrated, with testosterone levels of <50 ng/dL.
  • Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.
  • Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.
  • Relapsed or disease progression after having received ≥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 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.
  • 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.
  • 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.
  • Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:
  • 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
  • Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)
  • Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.

Who cannot join

  • Participants who meet any of the following criteria will be disqualified from entering the study:
  • 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.
  • Has nasopharyngeal cancer.
  • Has mucosal or uveal melanoma.
  • 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.
  • Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
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  • 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.
  • 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).
  • Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:
  • Adequately treated nonmelanoma skin cancer
  • Adequately treated intraepithelial carcinoma of the cervix
  • Any other curatively treated in situ disease
  • 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
  • Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.

Trial locations and contacts

96 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Daiichi Sankyo Contact for Clinical Trial Information contact

9089926400

CTRinfo@dsi.com

96 sites in 16 countries

United States14 sites, 13 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21205

    Recruiting

  • Roswell Park Cancer Institute IDS

    Buffalo, New York, 14203

    Recruiting

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • AdventHealth Medical Group Oncology Research at Celebration

    Kissimmee, Florida, 34747

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • Memorial Sloan Kettering Hospital

    New York, New York, 10065

    Recruiting

  • Maryland Oncology Hematology, PA

    Rockville, Maryland, 20850

    Recruiting

  • Health Partners Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

    Recruiting

  • Health Partners Cancer Center at Regions Hospital

    Saint Paul, Minnesota, 55101

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Completed

  • Washington University, School of Medicine

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Japan13 sites, 13 recruiting

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298

    Recruiting

  • HAKUAIKAI Social Medical Corporation Sagara Hospital

    Kagoshima, 892-0833

    Recruiting

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, 277-8577

    See Central Contact

    Recruiting

  • NHO Shikoku Cancer Center

    Matsuyama, 791-0245

    See Central Contact

    Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho, 411-8777

    See Central Contact

    Recruiting

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681

    Recruiting

  • Kindai University Hospital

    Osakasayama-shi, 589-8511

    See Central Contact

    Recruiting

  • Saitama Cancer Center

    Saitama, 362-0806

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045

    Recruiting

  • Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

    Recruiting

  • SHOWA Medical University Hospital

    Tokyo, 142-8666

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232-0024

    Recruiting

Other trials in Japan

France9 sites, 9 recruiting

  • Chu Bordeaux

    Bordeaux, 33000

    Recruiting

  • Centre Georges Franăois Leclerc

    Dijon, 21079

    Recruiting

  • Hopital Claude Huriez - Chu Lille

    Lille, 59000

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Recruiting

  • Hăpital de La Timone

    Marseille, 13005

    Recruiting

  • Chu Nantes - Hătel Dieu

    Nantes, 44093

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31100

    Recruiting

  • ICL - Alexis Vautrin

    Vandœuvre-lès-Nancy, 54500

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Spain9 sites, 9 recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

    Recruiting

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • HOSPITAL REGIONAL UNIVERSITARIO de MALAGA AVDA.

    Málaga, 29010

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

South Korea8 sites, 8 recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    Recruiting

  • National Cancer Center

    Gyeonggi-do, 410-769

    Recruiting

  • Cha Bundang Medical Center, Cha University

    Seongnam, 13496

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

Taiwan8 sites, 8 recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407219

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Recruiting

  • MacKay Memorial Hospital

    Taipei, 104217

    Recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 11209

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    See Central Contact

    Recruiting

  • Chang Gung Memorial Hospital

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Australia5 sites, 5 recruiting

  • Chris O'Brien Lifehouse

    Camperdown, 2050

    Recruiting

  • Icon Cancer Centre Chermside

    Chermside, 4032

    Recruiting

  • Monash Medical Centre Clayton

    Clayton, 3168

    Recruiting

  • Icon Cancer Centre Hobart

    Hobart, 7000

    Recruiting

  • Icon Cancer Centre Townsville

    Hyde Park, 4812

    Recruiting

Other trials in Australia

Belgium5 sites, 5 recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels

    Recruiting

  • UZA

    Edegem, 2650

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Recruiting

  • Universitair Ziekenhuis Brussel

    Jette

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

Netherlands5 sites, 5 recruiting

  • Amsterdam UMC locatie Vumc

    Amsterdam, 1081 HV

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Recruiting

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZG

    Recruiting

  • Maastricht University Medical Center

    Maastricht, 6229 HX

    Recruiting

  • Radboud University Medical Center

    Nijmegen, 6525 GA

    Recruiting

Other trials in Netherlands

United Kingdom5 sites, 5 recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • University Hospital Coventry

    Coventry, CV2 2DX

    Recruiting

  • Barts Hospital

    London, EC1A 7BE

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Recruiting

  • Nottingham City Hospital Campus

    Nottingham, NG5 1PB

    Recruiting

Other trials in United Kingdom

Canada4 sites, 3 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • Sunnybrook Research Institute

    Toronto, M4N 3M5

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, M5G2M9

    Completed

  • BC Cancer - Vancouver

    Vancouver, V5Z4E6

    Recruiting

Other trials in Canada

Italy4 sites, 4 recruiting

  • Humanitas Gavazzeni

    Bergamo, 24125

    Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

    Recruiting

  • AOU Federico II - Oncologia Clinica

    Naples, 80131

    Recruiting

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134

    Recruiting

Other trials in Italy

Norway3 sites, 1 recruiting

  • Akershus universitetssykehus

    Lørenskog, 1478

    Completed

  • Haukeland universitetssjukehus

    Lørenskog, 1478

    Completed

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, 0379

    Recruiting

Other trials in Norway

China2 sites, 2 recruiting

  • West China Hospital, Sichuan University

    Chengdu, 610098

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, 510060

    Recruiting

Other trials in China

Germany1 site, 1 recruiting

  • Krankenhaus Nordwest GmbH

    Frankfurt, 60488

    Recruiting

Other trials in Germany

Hungary1 site, 1 recruiting

  • Bacs-Kiskun Varmegyei Oktatokorhaz

    Kecskemét, 6000

    Recruiting

Other trials in Hungary

About this study

Official title: HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

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.

Read the detailed description

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.

Being tested
HER3-DXd
Keywords
Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer, Ovarian carcinoma, Cervical cancer, Endometrial cancer, Bladder cancer, Esophageal carcinoma, Pancreatic carcinoma, Prostate cancer, Patritumab Deruxtecan, HER3-DXd, U3-1402, Lung Cancer, Breast Cancer
Medical subject headings
Melanoma, Head and Neck Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Urinary Bladder Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HER3-DXdDrug

    Also called Patritumab Deruxtecan, U3-1402

    Intravenous infusion 5.6 mg/kg administered Q3W on Day 1 of each 21-day cycle

Study groups in NCT06172478
Study groupRoleWhat they receive
HER3-DXd MonotherapyExperimentalParticipants 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).
Receives: Drug: HER3-DXd

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)

    Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months

  2. Proportion of Participants Achieving a ≥50% Decrease in PSA (Prostate Cancer Cohort Only)

    Measured: Baseline, each cycle before infusion (each cycle is 21 days), and end of treatment, up to approximately 27 months

Secondary outcomes (16)

  1. Overall Number of Participants With Treatment-emergent Adverse Events Following HER3-DXd Monotherapy (All Cohorts)

    Adverse events (AEs) will be coded using MedDRA and AEs and will be graded by using NCI-CTCAE v5.0.

    Measured: Baseline up to 27 months

  2. Duration of Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)

    Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first documentation of progressive disease (PD) or death. The DoR will be calculated for responding participants (PR or CR) only.

    Measured: From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 27 months

  3. Clinical Benefit Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)

    Clinical benefit rate (CBR) is the proportion of participants with a best overall response of confirmed CR, confirmed PR, or SD lasting ≥183 days.

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months

  4. Disease Control Rate As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)

    Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) by investigator assessment per RECIST v1.1.

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months

  5. Time to Response As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)

    Time to response (TTR) will be calculated for confirmed responders only.

    Measured: From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 27 months

  6. Progression-free Survival As Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort)

    Measured: From the start date of study drug to the earlier date of the first objective documentation of radiographic disease progression as assessed by investigator per RECIST v1.1 or death due to any cause, whichever occurs first, up to approximately 27 months

  7. Overall Survival Following HER3-DXd Monotherapy (All Cohorts)

    Measured: From the start date of study drug to the date of death due to any cause, whichever occurs first, up to approximately 27 months

  8. Pharmacokinetic Parameter Maximum Serum Concentration for HER3-DXd (All Cohorts)

    Maximum serum concentration (Cmax) will be assessed using non-compartmental methods.

    Measured: Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)

  9. Pharmacokinetic Parameter Time to Maximum Serum Concentration for HER3-DXd (All Cohorts)

    Time to maximum serum concentration (Tmax) will be assessed using non-compartmental methods.

    Measured: Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)

  10. Pharmacokinetic Parameter Trough Serum Concentration (Ctrough) for HER3-DXd (All Cohorts)

    Trough serum concentration (Ctrough) will be assessed using non-compartmental methods.

    Measured: Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)

  11. Pharmacokinetic Parameter Area Under the Concentration Curve for HER3-DXd (All Cohorts)

    Area under the concentration-time curve up to the last quantifiable time (AUClast) and Area under the concentration-time curve during dosing interval (AUCtau) will be assessed using non-compartmental methods.

    Measured: Cycles 1-4, 6, 8: Day 1, predose and postdose; Cycles 1 and 3: Day 1, 2 hours and 4 hours postdose; Cycles 1 and 3: Day 8, Day 15 (each cycle is 21 days)

  12. Radiographic Progression-free Survival (rPFS) As Assessed by Prostate Cancer Working Group 3 (PCWG3) Criteria by the Investigator or Death Due to Any Cause Following HER3-DXd Monotherapy (Prostate Cancer Cohort Only)

    Measured: From the start date of study drug to the earlier date of the first objective documentation of radiographic disease progression as assessed per PCWG3 criteria by investigator or death due to any cause, whichever occurs first, up to approximately 27 months

  13. Proportion of Participants Achieving a ≥30% Decrease in PSA (Prostate Cancer Cohort Only)

    Measured: Baseline, each cycle before infusion (each cycle is 21 days), and end of treatment, up to approximately 27 months

  14. Time to First Subsequent Anticancer Therapy (TFST) (Prostate Cancer Cohort Only)

    Measured: From the start date of study drug to initiation of the first subsequent anticancer therapy or death, whichever occurs first, up to approximately 27 months

  15. Time to First Symptomatic Skeletal-Related Event (SSRE) (Prostate Cancer Cohort Only)

    Measured: From start date of study drug to the first occurrence of any of the following: Use of EBRT, New symptomatic pathologic bone fracture, Spinal cord compression, A tumor-related orthopedic surgical intervention, up to approximately 27 months

  16. Correlation Between HER3 Protein Expression and Efficacy

    HER3 protein expression in tumor tissue as determined by IHC and correlation with ORR, DoR, and PFS.

    Measured: From the start date of study drug up to approximately 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start26 Feb 2024
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion10 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
740 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06172478
Sponsor's protocol ID
U31402-277
Other IDs
2023-507641-29-00, jRCT2031230575, 2023
Status last verified
Sep 2026
First submitted
7 Dec 2023
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • 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.

    PubMed 41088723

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HER3-DXd in people with Advanced Solid Tumor and Melanoma, run by Daiichi Sankyo at 96 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 56 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Japan, France, Spain, South Korea and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daiichi Sankyo Contact for Clinical Trial Information (9089926400, CTRinfo@dsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Objective Response Rate Assessed by Investigator Following HER3-DXd Monotherapy (All Cohorts Except Prostate Cancer Cohort) (time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06172478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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