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21 Diseases |  |
1 Trial |
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1 Trial |  |
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- ||| DS-1062a / Daiichi Sankyo, patritumab (U3-1287) / Amgen
Daiichi Sankyo and Gustave Roussy Enter Innovative Research Collaboration for DXd ADCs DS-1062 and Patritumab Deruxtecan https://t.co/y7ft4VIhcA (Twitter) - Jul 21, 2020
- || Erbitux (cetuximab) / Eli Lilly, EMD Serono, patritumab (U3-1287) / Amgen
Clinical, P2 data, Journal: Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study. (Pubmed Central) - Jun 18, 2020
P2
Patritumab + cetuximab + platinum was tolerable but not superior to cetuximab + platinum.
- | 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
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.
- | Herceptin (trastuzumab) / Roche
Journal: Targeting of the HER2/HER3 signaling axis overcomes ligand-mediated resistance to trastuzumab in HER2-positive breast cancer. (Pubmed Central) - Apr 17, 2020
Finally, in heregulin-expressing BT474-HRG and JIMT-1 xenograft models, the addition of pertuzumab and patritumab to trastuzumab also enhanced antitumor efficacy leading to tumor regression. The current study found that triple blockade of HER2 and HER3 using trastuzumab, pertuzumab, and patritumab could overcome resistance to trastuzumab therapy in heregulin-expressing and HER2-positive breast cancer, which could be exploited clinically.
- || Erbitux (cetuximab) / Eli Lilly, EMD Serono, patritumab (U3-1287) / Amgen
Clinical, P1 data, Journal: Patritumab with Cetuximab Plus Platinum-Containing Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: An Open-Label, Phase-Ib Study. (Pubmed Central) - Feb 22, 2020
The current study found that triple blockade of HER2 and HER3 using trastuzumab, pertuzumab, and patritumab could overcome resistance to trastuzumab therapy in heregulin-expressing and HER2-positive breast cancer, which could be exploited clinically. Patritumab (18-mg/kg LD, 9-mg/kg MD) plus cetuximab/platinum was tolerable, active in SCCHN, and was selected as the phase II dose-regimen.
- | Biomarker, Enrollment change, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Feb 10, 2020
P2, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Patritumab (18-mg/kg LD, 9-mg/kg MD) plus cetuximab/platinum was tolerable, active in SCCHN, and was selected as the phase II dose-regimen. N=1920 --> 4000
- | R3Mab / Roche, patritumab (U3-1287) / Amgen
Journal: Novel functional anti-HER3 monoclonal antibodies with potent anti-cancer effects on various human epithelial cancers. (Pubmed Central) - Feb 1, 2020
Ab4 inhibited in vivo tumor growth of human colon cancer cells in nude mice. Present mAbs may be superior to existing anti-HER3 mAbs and support existing anti-cancer therapeutic mAbs.
- | Biomarker, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Jan 22, 2020
P2, N=1920, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Present mAbs may be superior to existing anti-HER3 mAbs and support existing anti-cancer therapeutic mAbs. Trial primary completion date: Dec 2020 --> Dec 2025
- Evaluation of patritumab/paclitaxel/trastuzumab over standard paclitaxel/trastuzumab in early stage, high-risk HER2 positive breast cancer: Results from the neoadjuvant I-SPY 2 TRIAL (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1974;
The I-SPY 2 study aims to assess the probability that investigational regimens will be successful in a phase 3 neoadjuvant trial; PTH was stopped due to safety concerns, although there was activity in the HER2+ HR- signature. This is the first report of Gr3 hearing loss associated with patritumab/paclitaxel/trastuzumab, and thus attribution is uncertain.
- ||||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial termination, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) (clinicaltrials.gov) - Jan 7, 2019
P2, N=87, Terminated, Sponsor: Daiichi Sankyo, Inc.
This is the first report of Gr3 hearing loss associated with patritumab/paclitaxel/trastuzumab, and thus attribution is uncertain. Completed --> Terminated; Trial was terminated by sponsor due to lack of efficacy.
- |||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial completion, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) (clinicaltrials.gov) - Mar 30, 2018
P2, N=87, Completed, Sponsor: Daiichi Sankyo, Inc.
Completed --> Terminated; Trial was terminated by sponsor due to lack of efficacy. Active, not recruiting --> Completed
- || patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) (clinicaltrials.gov) - Mar 3, 2018
P2, N=87, Active, not recruiting, Sponsor: Daiichi Sankyo, Inc.
Active, not recruiting --> Completed Trial completion date: May 2018 --> Feb 2018 | Trial primary completion date: Feb 2018 --> Jan 2018
- | patritumab (U3-1287) / Amgen, Daiichi Sankyo
Phase classification, Combination therapy, Metastases: Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Nov 20, 2017
P1b/2, N=222, Completed, Sponsor: Daiichi Sankyo, Inc.
Trial completion date: May 2018 --> Feb 2018 | Trial primary completion date: Feb 2018 --> Jan 2018 Phase classification: P1/2 --> P1b/2
- | Biomarker, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Oct 20, 2017
P2, N=1920, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Phase classification: P1/2 --> P1b/2 Trial primary completion date: Dec 2018 --> Dec 2020
- | patritumab (U3-1287) / Amgen, Daiichi Sankyo
Phase classification, Trial termination, Trial primary completion date: Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC) (clinicaltrials.gov) - Oct 17, 2017
P1b/2, N=29, Terminated, Sponsor: Daiichi Sankyo, Inc.
Trial primary completion date: Dec 2018 --> Dec 2020 Phase classification: P1/2 --> P1b/2 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2015 --> Jan 2015; Improved, different standard of care caused business decision to terminate
- | patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial termination, Trial primary completion date, Combination therapy, Metastases: Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung) (clinicaltrials.gov) - Aug 28, 2017
P3, N=724, Terminated, Sponsor: Daiichi Sankyo, Inc.
Phase classification: P1/2 --> P1b/2 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2015 --> Jan 2015; Improved, different standard of care caused business decision to terminate Active, not recruiting --> Terminated | Trial primary completion date: Jun 2018 --> Nov 2016; Pre-defined criteria for continuation were not reached
- || patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial primary completion date, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) (clinicaltrials.gov) - Aug 24, 2017
P2, N=87, Active, not recruiting, Sponsor: Daiichi Sankyo, Inc.
Active, not recruiting --> Terminated | Trial primary completion date: Jun 2018 --> Nov 2016; Pre-defined criteria for continuation were not reached Trial primary completion date: Jul 2017 --> Oct 2017
- ||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
Enrollment closed, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) (clinicaltrials.gov) - Jun 27, 2017
P2, N=105, Active, not recruiting, Sponsor: Daiichi Sankyo Inc.
Trial primary completion date: Jul 2017 --> Oct 2017 Recruiting --> Active, not recruiting
- || patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial primary completion date, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) (clinicaltrials.gov) - May 1, 2017
P2, N=105, Recruiting, Sponsor: Daiichi Sankyo Inc.
Recruiting --> Active, not recruiting Trial primary completion date: Apr 2017 --> Jul 2017
- Biomarker, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Dec 7, 2016
P2, N=1920, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Trial primary completion date: Apr 2017 --> Jul 2017 Trial primary completion date: May 2018 --> Dec 2018
- ||||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
Enrollment closed, Combination therapy, Metastases: Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung) (clinicaltrials.gov) - Sep 27, 2016
P3, N=724, Active, not recruiting, Sponsor: Daiichi Sankyo Inc.
Trial primary completion date: May 2018 --> Dec 2018 Recruiting --> Active, not recruiting
- | patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial completion, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer (clinicaltrials.gov) - Aug 24, 2016
P1b, N=15, Completed, Sponsor: Daiichi Sankyo Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- Biomarker, Enrollment change, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Jul 13, 2016
P2, N=1920, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Active, not recruiting --> Completed N=1200 --> 1920 | Trial primary completion date: Sep 2017 --> May 2018
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial primary completion date: Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC) (clinicaltrials.gov) - Feb 29, 2016
P1/2, N=29, Active, not recruiting, Sponsor: Daiichi Sankyo Inc.
N=1200 --> 1920 | Trial primary completion date: Sep 2017 --> May 2018 Trial primary completion date: Dec 2013 --> Jul 2015
- ||||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
New P2 trial, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) (clinicaltrials.gov) - Dec 17, 2015
P2, N=105, Recruiting, Sponsor: Daiichi Sankyo Inc.
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
Enrollment closed, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer (clinicaltrials.gov) - Dec 14, 2015
P1b, N=15, Active, not recruiting, Sponsor: Daiichi Sankyo Inc.
Trial primary completion date: Dec 2013 --> Jul 2015 Recruiting --> Active, not recruiting
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial primary completion date, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer (clinicaltrials.gov) - Jun 11, 2015
P1b, N=18, Recruiting, Sponsor: Daiichi Sankyo Inc.
Recruiting --> Active, not recruiting Trial primary completion date: May 2015 --> May 2016
- Biomarker, Enrollment change, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Jun 11, 2015
P2, N=1200, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Trial primary completion date: May 2015 --> May 2016 N=800 --> 1200 | Trial primary completion date: Sep 2015 --> Sep 2017
- | patritumab (U3-1287) / Amgen, Daiichi Sankyo
Enrollment change: Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC) (clinicaltrials.gov) - May 21, 2015
P1/2, N=29, Active, not recruiting, Sponsor: Daiichi Sankyo Inc.
N=800 --> 1200 | Trial primary completion date: Sep 2015 --> Sep 2017 N=86 --> 29
- | patritumab (U3-1287) / Amgen, Daiichi Sankyo
New P1 trial, Combination therapy, Metastases: Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer (clinicaltrials.gov) - Jan 30, 2015
P1b, N=18, Recruiting, Sponsor: Daiichi Sankyo Inc.
- Biomarker, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Sep 22, 2014
P2, N=800, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
N=86 --> 29 Trial primary completion date: Feb 2014 --> Sep 2015
- || patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial completion date: Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC) (clinicaltrials.gov) - May 18, 2014
P1/2, N=86, Active, not recruiting, Sponsor: Daiichi Sankyo Inc.
Trial primary completion date: Feb 2014 --> Sep 2015 Trial completion date: May 2014 --> Sep 2014
- ||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
Enrollment closed: Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC) (clinicaltrials.gov) - May 18, 2014
P1/2, N=86, Active, not recruiting, Sponsor: Daiichi Sankyo Inc.
Trial completion date: May 2014 --> Sep 2014 Recruiting --> Active, not recruiting
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial completion date, Metastases: Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287) (clinicaltrials.gov) - May 12, 2014
P1, N=17, Completed, Sponsor: Daiichi Sankyo Inc.
Recruiting --> Active, not recruiting Trial completion date: Mar 2014 --> Apr 2014
- | patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial completion, Metastases: Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287) (clinicaltrials.gov) - May 12, 2014
P1, N=17, Completed, Sponsor: Daiichi Sankyo Inc.
Trial completion date: Mar 2014 --> Apr 2014 Recruiting --> Completed
- |||||||||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
New P3 trial, Combination therapy, Metastases: Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung) (clinicaltrials.gov) - May 6, 2014
P3, N=780, Recruiting, Sponsor: Daiichi Sankyo Inc.
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial termination, Metastases: Evaluation of 64Cu-DOTA-U3-1287 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Dec 18, 2013
P1, N=12, Terminated, Sponsor: Washington University School of Medicine
Recruiting --> Completed Recruiting --> Terminated; treatment was not working
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
Enrollment change, Metastases: Evaluation of 64Cu-DOTA-U3-1287 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Dec 18, 2013
P1, N=12, Terminated, Sponsor: Washington University School of Medicine
Recruiting --> Terminated; treatment was not working N=25 --> 12
- |||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
Trial completion, Combination therapy, Metastases: Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Dec 3, 2013
P1/2, N=222, Completed, Sponsor: Daiichi Sankyo Inc.
N=25 --> 12 Active, not recruiting --> Completed
- | patritumab (U3-1287) / Amgen, Daiichi Sankyo
New P1 trial, Metastases: Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287) (clinicaltrials.gov) - Oct 6, 2013
P1, N=17, Recruiting, Sponsor: Daiichi Sankyo Inc.
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
New P2 trial, Combination therapy, Metastases: Open-label, Non-randomized Study of U3-1287 in Combination with Erlotinib in Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC) - Extension (EUDRACT) - Apr 4, 2013
P2, N=9, Ongoing, Sponsor: DAIICHI SANKYO DEVELOPMENT LTD.
- ||||| patritumab (U3-1287) / Amgen, Daiichi Sankyo
New P1/2 trial: Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC) (clinicaltrials.gov) - Jan 17, 2012
P1/2, N=86, Recruiting, Sponsor: Daiichi Sankyo Inc.
- patritumab (U3-1287) / Amgen, Daiichi Sankyo
New P1 trial, Metastases: Evaluation of 64Cu-DOTA-U3-1287 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Nov 22, 2011
P1, N=12, Terminated, Sponsor: Washington University School of Medicine