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8 Trials |  |
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- patritumab deruxtecan (U3-1402) / Daiichi Sankyo
[VIRTUAL] HERTHENA-Lung01: A Randomized Phase 2 Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Previously Treated Metastatic EGFR-mutated NSCLC (ePoster Hall) - Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_377;
Anticipated total study duration is expected to be 26 months, consisting of approximately 12 months for enrollment and 14 months on treatment. The study is planned to begin in 2020.
- |||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo
U3-1402 HER-3 ADC spotlight 🔆 presentation ✳️ORR 30.3% ✳️mPFS 8.4 months, no difference by HER-3 expression ⚠️1 fatal pneumonitis ❓is HER-3 expression needed? #SABCS20 @OncoAlert #bcsm (Twitter) - Dec 9, 2020
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo
[VIRTUAL] An open-label, phase II study of patritumab deruxtecan (HER3-DXd, U3-1402) in patients (pts) with previously treated advanced/metastatic colorectal cancer (CRC). () - Dec 9, 2020 - Abstract #ASCOGI2021ASCO_GI_408;
P2
ORR will be summarized with the 2-sided 95% confidence interval. Secondary objectives include the evaluation of efficacy as measured by ORR (assessed by investigator according to RECIST v1.1), duration of response, time to tumor response, disease control rate, progression-free survival (assessed by investigator and BICR according to RECIST v1.1), overall survival, safety and tolerability, HER3 protein expression in tumor tissue and relationship with efficacy, and pharmacokinetic properties.
- || patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: U31402-A-J101: Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer (clinicaltrials.gov) - Dec 3, 2020
P1/2, N=180, Active, not recruiting, Sponsor: Daiichi Sankyo Co., Ltd.
Secondary objectives include the evaluation of efficacy as measured by ORR (assessed by investigator according to RECIST v1.1), duration of response, time to tumor response, disease control rate, progression-free survival (assessed by investigator and BICR according to RECIST v1.1), overall survival, safety and tolerability, HER3 protein expression in tumor tissue and relationship with efficacy, and pharmacokinetic properties. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Sep 2020 --> Feb 2021
- ||||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
New P2 trial, Metastases: HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 5, 2020
P2, N=300, Not yet recruiting, Sponsor: Daiichi Sankyo, Inc.
- | patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
New P1 trial: SOLTI TOT-HER3: A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression (clinicaltrials.gov) - Oct 29, 2020
P1, N=80, Not yet recruiting, Sponsor: SOLTI Breast Cancer Research Group
- ||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
Patritumab Deruxtecan Poised for Phase 2 Exploration in HER3+ Advanced CRC @GillesJAGallant #crcsm https://t.co/hIDuk9obZD (Twitter) - Oct 27, 2020
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo
[VIRTUAL] Safety and efficacy results from the phase 1/2 study of U3-1402, a human epidermal growth factor receptor 3 (HER3)-directed antibody drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC) (Channel 1) - Oct 2, 2020 - Abstract #SABCS2020SABCS_1164;
P1/2
The safety profile of U3-1402 was consistent with that previously reported, with 9% of patients discontinuing because of AEs. Clinical data pertaining to patients with TNBC and correlative analyses (including association of HER3 expression with response) will be presented.
- ||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
既治療のEGFR遺伝子変異陽性の進行NSCLCに抗HER3抗体薬物複合体patritumab deruxtecanが有望 https://t.co/eGbQzH9EvL #ADC @DaiichiSankyoJP (Twitter) - Sep 25, 2020
- || patritumab deruxtecan (U3-1402) / Daiichi Sankyo
Clinical, Journal: A Novel HER3-Targeting Antibody-Drug Conjugate, U3-1402, Exhibits Potent Therapeutic Efficacy through the Delivery of Cytotoxic Payload by Efficient Internalization. (Pubmed Central) - Sep 23, 2020
U3-1402 demonstrated promising antitumor activity against HER3-expressing tumors with tolerable safety profiles. The activity of U3-1402 was driven by HER3-mediated payload delivery via high internalization into tumor cells.
- ||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
New data on patritumab deruxtecan data was presented at #ESMO20 by @HelenaYu923. This is an interesting molecule and mechanism of action - wanted to go through this great presentation. Also kudos to @MLJohnsonMD2 @ConorSteuerMD and others! #LCSM (Twitter) - Sep 20, 2020
- |||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Trodelvy (sacituzumab govitecan-hziy) / Immunomedics, Everest Medicines, patritumab (U3-1287) / Amgen
With this ADC,the treatment of many orphan&Common tumors will soon find a solution, and it seems that all the standard treatment options we know of for most tumors will change. Sacituzumab govitecan, patritumab deruxtecan (U3-1402) and others. This ESMO Theme is ADC&Hope (Twitter) - Sep 20, 2020
- |||||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
Clinical: #ESMO20 Dr. @HelenaYu923 presents data on patritumab deruxtecan (U3-1402), a HER3-ADC for patients with #EGFR mutant NSCLC. #LCSM @OncoAlert (Twitter) - Sep 20, 2020
- |||| #ESMO20 We are seeing promising activity with mobocertinib in EGFRex20, patritumab deruxtecan in sensitizing #EGFR, and tarloxotinib and poziotinib in #HER2, but some toxicity concerns with poziotinib at this dose schedule. Nice discussion @ZerAlona #LCSM #OncoAlert (Twitter) - Sep 18, 2020
- |||| #ESMO20 Nice discussion of the #EGFR / #HER2 #NSCLC abstracts from @ZerAlona covering poziotinib, tarloxotinib, mobocertinib, and patritumab deruxtecan. #LCSM #OncoAlert (Twitter) - Sep 18, 2020
- ||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
Enrollment open, Metastases: A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov) - Sep 16, 2020
P2, N=80, Recruiting, Sponsor: Daiichi Sankyo, Inc.
The activity of U3-1402 was driven by HER3-mediated payload delivery via high internalization into tumor cells. Not yet recruiting --> Recruiting
- patritumab deruxtecan (U3-1402) / Daiichi Sankyo, patritumab (U3-1287) / Amgen
[VIRTUAL] Efficacy and safety of patritumab deruxtecan (U3-1402), a novel HER3 directed antibody drug conjugate, in patients (pts) with EGFR-mutated (EGFRm) NSCLC (On-Demand) - Aug 27, 2020 - Abstract #ESMO2020ESMO_3512;
P1
Funding: Daiichi Sankyo. Clinical trial identification: NCT03260491.
- | patritumab deruxtecan (U3-1402) / Daiichi Sankyo
Journal, PD(L)-1 Biomarker, IO Biomarker: U3-1402 sensitizes HER3-expressing tumors to PD-1 blockade by immune activation. (Pubmed Central) - Jul 22, 2020
Further, clinical analyses indicated that tumor-specific HER3 expression was frequently observed in patients with PD-1 inhibitor-resistant solid tumors. Overall, U3-1402 is a promising candidate as a partner of immunotherapy for such patients.
- |||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
New P2 trial, Metastases: A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov) - Jul 20, 2020
P2, N=80, Not yet recruiting, Sponsor: Daiichi Sankyo, Inc.
- | U3-1402 / Daiichi Sankyo, irinotecan / Generic mfg.
Journal: U3-1402, a novel HER3-targeting antibody-drug conjugate, for the treatment of Colorectal Cancer. (Pubmed Central) - Jun 4, 2020
The antitumor activity of U3-1402 was dependent on HER3 expression level, but not on KRAS mutation status. These results support further investigation of development strategies for U3-1402 in patients with HER3-expressing CRC.
- U3-1402 / Daiichi Sankyo
Pan-cancer gene expression analysis of tissue microarray using EdgeSeq Oncology Biomarker Panel and a cross-comparison with ERBB3 immunohistochemical analysis (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_935;
These results suggested a unique protein-level regulation of ERBB3 in tumor cells. It would be important to investigate the significance of protein-level antibody-target expressions on tumor samples, such as IHC on tissue microarray, for antibody-based drug development.
- U3-1402 / Daiichi Sankyo
U3-1402, a novel HER3-targeting antibody-drug conjugate, exhibits in vitro antitumor activity against breast cancer cells expressing HER3 mutations without dependence on HER2 overexpression (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1067;
P1, P1/2
U3-1402 has a potential to show antitumor activity against HER3 mutant cells with the same potency as HER3WT cells, regardless of HER2 overexpression. This finding provides insights into HER3-targeted therapy, in which an efficient payload delivery via ADC-mediated internalization could be achieved for HER3 mutations.
- U3-1402 / Daiichi Sankyo
HER3-targeting antibody-drug conjugate, U3-1402, induces tumor regression in a variety of xenograft models and exerts enhanced antitumor activity by combining with PI3K inhibition (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1066;
P1, P1/2
U3-1402 may exert potent antitumor activity in various human cancer cells expressing HER3, and its efficacy is likely to be enriched by HER3 expression. A combination strategy with agents that upregulate HER3 expression, such as PI3K inhibitors, should be explored further given this observed benefit over monotherapy.
- U3-1402 / Daiichi Sankyo
EGFR inhibition enhances the cellular uptake and antitumor activity of the novel HER3 antibody drug conjugate U3-1402 (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1059;
P1
HER3 is frequently over expressed in EGFR-mutant NSCLC.U3-1402 is an antibody-drug conjugate (ADC) comprised of HER3-targeting antibody (patritumab) linked to a topoisomerase I inhibitor (DX-8951 derivative, or DXd)...We aimed to develop a preclinical strategy to enhance the efficacy of U3-1402.Pre-treatment with EGFR TKIs (gefitinib or osimertinib) increased HER3 membrane levels in six different EGFR-mutant cell lines by increasing both the amount of HER3 positive cells and the intensity of HER3 expression...In vivo experiments evaluating the antitumor efficacy of the combination of osimertinib and U3-1402 are currently underway.Our studies reveal that EGFR inhibitor treatment increased membrane expression of HER3 which was associated with enhanced internalization of U3-1402 in EGFR-mutant NSCLC. The combination of osimertinib and U3-1402 may be an effective treatment approach and should be evaluated in future clinical trials in patients with EGFR-mutant NSCLC.
- U3-1402 / Daiichi Sankyo
[VIRTUAL] ERBB3 mRNA expression in breast cancer (BC): A SOLTI biomarker discovery analysis (Channel 2) - Apr 17, 2020 - Abstract #ESMOBCI2020ESMO_BC_I_134;
The assay using FFPE tissues is feasible and reliable. The predictive value of this biomarker will be prospectively tested in the upcoming SOLTI-1805 TOT-HER3 window trial using the U3-1402 anti-HER3 antibody-drug conjugate.Legal entity responsible for the study: SOLTI Breast Cancer Group.
- || patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
Enrollment closed, Metastases: U31402-A-J101: Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer (clinicaltrials.gov) - Apr 6, 2020
P1/2, N=180, Active, not recruiting, Sponsor: Daiichi Sankyo Co., Ltd.
The predictive value of this biomarker will be prospectively tested in the upcoming SOLTI-1805 TOT-HER3 window trial using the U3-1402 anti-HER3 antibody-drug conjugate.Legal entity responsible for the study: SOLTI Breast Cancer Group. Recruiting --> Active, not recruiting
- || U3-1402 / Daiichi Sankyo
P1/2 data, Journal: Single agent activity of U3-1402, a HER3-targeting antibody-drug conjugate, in HER3-overexpressing metastatic breast cancer: Updated results from a phase I/II trial. (Pubmed Central) - Feb 23, 2020
Recruiting --> Active, not recruiting No abstract available
- U3-1402 / Daiichi Sankyo
U3-1402 (HER3-directed ADC) (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_208;
- || patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
Enrollment change, Metastases: U31402-A-U102: HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jan 18, 2020
P1, N=198, Recruiting, Sponsor: Daiichi Sankyo, Inc.
No abstract available N=130 --> 198
- | Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open: KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-na (clinicaltrials.gov) - Jan 13, 2020
P2, N=90, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=130 --> 198 Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD)
New P2 trial: KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-na (clinicaltrials.gov) - Nov 15, 2019
P2, N=90, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- U3-1402 / Daiichi Sankyo
Phase 1/2 first-in-human study of U3-1402, an anti-human epidermal growth factor receptor 3 (HER3) antibody-drug conjugate, in HER3-expressing advanced/unresectable or metastatic breast cancer, including those with triple negative breast cancer (TNBC) or HER3-low disease (Hall 1 - Poster Session 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1333;
P1/2
Efficacy assessments include investigator-assessed objective response rate per RECIST v1.1, response duration, time to response, clinical benefit rate, progression-free survival, overall survival, and percent change in target lesion(s). Patients receiving at least 1 dose of U3-1402 with pretreatment and posttreatment tumor assessments will be evaluated for efficacy.
- ||||| U3-1402 / Daiichi Sankyo, SAR408701 / Sanofi, DS-1062a / Daiichi Sankyo
The raise of smart chemos : 3 examples of ADCs (antibody-drug conjugate) presented at #ASCO19: - SAR408701 in CEACAM5+ NSCLC, - U3-1402 against HER3 in EGFRmut NSCLC, - DS-1062a (ADC against TROP2) in all comers NSCLC. Future options post CT-IO combos? (Twitter) - Jun 2, 2019
- |||| U3-1402 / Daiichi Sankyo
Stayed home to watch 5th grade Willy Wonka musical this AM, just landed in Chicago. So excited to learn and connect w/ friends old and new at #ASCO19. #ASCOiSpy Missed Lung CA CSS but thanks to @Jbauml @n8pennell I’m not behind. Super excited to see data on JNJ372, U3-1402! (Twitter) - May 31, 2019
- |||||| U3-1402 / Daiichi Sankyo
Clinical: Oral presentation on “Safety and Preliminary Antitumor Activity of U3-1402: A HER3-Targeted Antibody Drug Conjugate in EGFR TKI-Resistant, EGFRm NSCLC” will feature @MLJohnsonMD2- @ASCO Scientific Chair 2019-2020 @1:24 Hall D1 (Twitter) - May 31, 2019
- ||||| U3-1402 / Daiichi Sankyo
Fantastic point by Dr Bauman on the U3-1402 study. While HER3 expression was universal, there did not seem to be a quantitative correlation between extent of overexpression and response to the agent. #LCSM #ASCO19 (Twitter) - May 31, 2019
- ||| U3-1402 / Daiichi Sankyo, repotrectinib (TPX-0005) / TP Therap
No, no, no. The hottest CSS is on Friday at 1:00! Hall D1 "EGFR and ROS1: Targeting Resistance" Presentations on data for JNJ-372, U3-1402, and repotrectinib. Discussants: @politikaterina Jessica Bauman, @BenjaminBesseMD (Twitter) - May 30, 2019
- || patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
Enrollment change, Trial completion date, Trial primary completion date, Metastases: U31402-A-U102: HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - May 21, 2019
P1, N=130, Recruiting, Sponsor: Daiichi Sankyo, Inc.
Patients receiving at least 1 dose of U3-1402 with pretreatment and posttreatment tumor assessments will be evaluated for efficacy. N=63 --> 130 | Trial completion date: Feb 2020 --> Oct 2023 | Trial primary completion date: Feb 2020 --> Oct 2021
- |||| U3-1402 / Daiichi Sankyo, JNJ-61186372 / Genmab, J&J
These are two exciting abstracts targeting disease in people who have EGFR mutant NSCLC with resistance to EGFR TKI U3-1402, a HER3 ADC https://t.co/I1WMisFm3o JNJ-61186372, an EGFR/MET bispecific Ab https://t.co/1i14HxAJnt (Twitter) - May 16, 2019
- | patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
New P1 trial, Metastases: U31402-A-U102: HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jan 18, 2019
P1, N=63, Not yet recruiting, Sponsor: Daiichi Sankyo, Inc.
- | patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
Enrollment change, Metastases: U31402-A-J101: Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer (clinicaltrials.gov) - Aug 28, 2018
P1/2, N=140, Recruiting, Sponsor: Daiichi Sankyo Co., Ltd.
N=63 --> 130 | Trial completion date: Feb 2020 --> Oct 2023 | Trial primary completion date: Feb 2020 --> Oct 2021 N=80 --> 140
- || patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: U31402-A-J101: Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer (clinicaltrials.gov) - Mar 12, 2018
P1/2, N=80, Recruiting, Sponsor: Daiichi Sankyo Co., Ltd.
N=80 --> 140 Trial completion date: Dec 2018 --> Dec 2020 | Trial primary completion date: Sep 2018 --> Sep 2020
- | patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
Enrollment open, Trial primary completion date, Metastases: U31402-A-U102: HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 21, 2017
P1, N=63, Recruiting, Sponsor: Daiichi Sankyo, Inc.
Trial completion date: Dec 2018 --> Dec 2020 | Trial primary completion date: Sep 2018 --> Sep 2020 Not yet recruiting --> Recruiting | Trial primary completion date: Oct 2017 --> Feb 2020
- ||||| patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD)
New P1/2 trial, Metastases: U31402-A-J101: Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer (clinicaltrials.gov) - Dec 2, 2016
P1/2, N=80, Recruiting, Sponsor: Daiichi Sankyo Co., Ltd.