臨床研究等提出・公開システム

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 (HERTHENA-PanTumor01)

Phase 2 Study of HER3-DXd in Locally Advanced or Metastatic Solid Tumors (HERTHENA-PanTumor01)

Inoguchi Akihiro

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Recruiting

Feb. 01, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Sign and date the ICF, 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. Is a male or female 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:
3-1. Cutaneous or acral melanoma
a. Histologically or cytologically confirmed cutaneous or acral melanoma
b. Disease progression after having received >=1 prior line of anti-PD-1 or anti-PD-L1 based therapy. If the subject had BRAFm melanoma, they must have had disease progression on BRAF/MEK inhibitor therapy as well.
OR
3-2. Squamous cell carcinomas of the head and neck
c. Squamous cell carcinoma of the head and neck that is human papillomavirus (HPV) positive or negative. Primary tumor site must have arisen initially from the oral cavity, oropharynx, hypopharynx, or larynx. Tumors arising from the nasopharynx are excluded.
d. Disease progression after having received treatment with a PBC regimen with or without anti-PD-1 therapy
OR
3-3. Gastric or GEJ adenocarcinoma
e. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry [IHC] 0/1+ or IHC 2+/in situ hybridization negative) 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.
f. Disease progression after having received treatment with a previous PBC with or without anti-PD-1 therapy.
4. Has >=1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment.
5. Provides a pretreatment tumor tissue sample of sufficient quantity, as defined in the Study Laboratory Manual. The pretreatment tumor tissue can be provided as either
a. Tissue collected from a biopsy performed since progression while on or after treatment with the most recent cancer therapy regimen and prior to signing of the tissue ICF
OR
b. Pretreatment tumor biopsy from >=1 lesion not previously irradiated and amenable to sampling
The pretreatment tissue requirement may be waived after discussion and agreement with the Sponsor.
6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.

1. Has HER2-positive gastric cancer 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.
2. Has nasopharyngeal cancer.
3. Has mucosal or uveal melanoma.
4. Has any history of interstitial lung disease (ILD; including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during 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 or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Subjects 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 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:
a. Adequately treated nonmelanoma skin cancer
b. Adequately treated intraepithelial carcinoma of the cervix
c. 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.

Both

Locally Advanced or Metastatic Solid Tumors

Patritumab deruxtecan (HER3-DXd) will be administered as an intravenous solution every 3 weeks on Day 1 of each 21-day cycle at a dose of 5.6 mg/kg.

Objective Response Rate (ORR) as assessed by the investigator per RECIST v1.1

Treatment-emergent adverse events (TEAEs) and other safety parameters during the study, duration of response (DOR), clinical benefit rate (CBR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS), overall survival (OS), PK endpoints (serum concentrations and PK parameters of HER3-DXd), correlation between HER3 protein expression at baseline and efficacy

+81-3-3520-0111

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/ Supporting Information: -Study Protocol -Statistical Analysis Plan (SAP) -Informed Consent Form (ICF) Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. URL: https://vivli.org/ourmember/daiichi-sankyo/

United States/Korea/France/United Kingdom/Taiwan/Spain/Australia/Belgium