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- || AB-329 / Baoyuan Biopharma, Tagrisso (osimertinib) / AstraZeneca
P1 data, Clinical Trial,Phase I, Journal, Metastases: Evaluation of combination treatment with DS-1205c, an AXL kinase inhibitor, and osimertinib in metastatic or unresectable EGFR-mutant non-small cell lung cancer: results from a multicenter, open-label phase 1 study. (Pubmed Central) - May 1, 2023
P1
DS-1205c was well-tolerated with no new safety signals in patients with advanced EGFR-mutant NSCLC when administered in combination with the EFGR TKI osimertinib. ClinicalTrials.gov ; NCT03255083.
- || AB-329 / Baoyuan Biopharma
P1 data, Clinical Trial,Phase I, Journal: Phase 1 study of DS-1205c combined with gefitinib for EGFR mutation-positive non-small cell lung cancer. (Pubmed Central) - Apr 5, 2023
P1
DS-1205c was generally safe and well tolerated at all dose levels, but the safety profile of ?800?mg BID was more favorable than 1200?mg BID. The recommended dose for dose-expansion cohorts of DS-1205c in combination therapy with gefitinib was 800?mg BID.
- || AB-329 / Baoyuan Biopharma
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases: DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jul 6, 2021
P1, N=13, Completed, Sponsor: Daiichi Sankyo, Inc.
The recommended dose for dose-expansion cohorts of DS-1205c in combination therapy with gefitinib was 800?mg BID. Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Sep 2020 | Trial primary completion date: Apr 2021 --> Sep 2020
- AB-329 / Baoyuan Biopharma, Tagrisso (osimertinib) / AstraZeneca
[VIRTUAL] Phase 1 Study of the AXL Inhibitor DS-1205 in Combination With Osimertinib in Subjects With Metastatic or Unresectable EGFR-Mutant NSCLC (ePoster Hall) - Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_1580;
Preliminary analysis of efficacy data reveals that three patients had stable disease beyond 100 days (RECIST v.1.1). Conclusion Dose escalation is ongoing and updated clinical and biomarker data will be presented.
- AB-329 / Baoyuan Biopharma, gefitinib / Generic mfg.
[VIRTUAL] A first-in-human phase I study of the AXL inhibitor DS-1205c in combination with gefitinib in subjects with EGFR-mutant NSCLC (On-Demand) - Jul 21, 2020 - Abstract #ESMO2020ESMO_851;
P1
Funding: Daiichi Sankyo. Clinical trial identification: NCT03599518.
- || AB-329 / Baoyuan Biopharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jul 7, 2020
P1, N=21, Completed, Sponsor: Daiichi Sankyo Co., Ltd.
Clinical trial identification: NCT03599518. Active, not recruiting --> Completed | N=63 --> 21 | Trial completion date: Mar 2021 --> Jun 2020 | Trial primary completion date: Mar 2021 --> Apr 2020
- || AB-329 / Baoyuan Biopharma
Enrollment closed, Enrollment change, Combination therapy, Metastases: DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jun 25, 2020
P1, N=13, Active, not recruiting, Sponsor: Daiichi Sankyo, Inc.
Active, not recruiting --> Completed | N=63 --> 21 | Trial completion date: Mar 2021 --> Jun 2020 | Trial primary completion date: Mar 2021 --> Apr 2020 Recruiting --> Active, not recruiting | N=21 --> 13
- DS-1205 / Daiichi Sankyo, Tagrisso (osimertinib) / AstraZeneca
[VIRTUAL] Phase I study of the AXL inhibitor DS-1205c in combination with osimertinib in subjects with metastatic or unresectable EGFR-mutant non-small cell lung cancer (NSCLC). () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5640;
- DS-1205 / Daiichi Sankyo, gefitinib / Generic mfg.
[VIRTUAL] A first-in-human phase I study of the AXL inhibitor DS-1205c in combination with gefitinib in subjects with metastatic or unresectable EGFR-mutant NSCLC. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_3797;
- || AB-329 / Baoyuan Biopharma
Enrollment closed, Combination therapy, Metastases: DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 6, 2020
P1, N=63, Active, not recruiting, Sponsor: Daiichi Sankyo Co., Ltd.
Recruiting --> Active, not recruiting | N=21 --> 13 Recruiting --> Active, not recruiting
- DS-1205 / Daiichi Sankyo
DS1205 (AXL) (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_201;
- | DS-1205 / Daiichi Sankyo
Preclinical, Journal: DS-1205b, a novel selective inhibitor of AXL kinase, blocks resistance to EGFR-tyrosine kinase inhibitors in a non-small cell lung cancer xenograft model. (Pubmed Central) - Sep 10, 2019
DS-1205b also delayed the onset of resistance when used in combination with osimertinib in the model. These findings strongly suggest that DS-1205b can prolong the therapeutic benefit of EGFR TKIs in nonclinical as well as clinical settings.
- || AB-329 / Baoyuan Biopharma
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 16, 2019
P1, N=18, Recruiting, Sponsor: Daiichi Sankyo, Inc.
These findings strongly suggest that DS-1205b can prolong the therapeutic benefit of EGFR TKIs in nonclinical as well as clinical settings. N=118 --> 18 | Trial completion date: Oct 2020 --> Jun 2021 | Trial primary completion date: Oct 2020 --> Jun 2021
- | AB-329 / Baoyuan Biopharma
New P1 trial, Combination therapy, Metastases: DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Dec 24, 2018
P1, N=63, Not yet recruiting, Sponsor: Daiichi Sankyo Co., Ltd.
- | AB-329 / Baoyuan Biopharma
Enrollment open, Combination therapy, Metastases: DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Aug 31, 2018
P1, N=63, Recruiting, Sponsor: Daiichi Sankyo Co., Ltd.
N=118 --> 18 | Trial completion date: Oct 2020 --> Jun 2021 | Trial primary completion date: Oct 2020 --> Jun 2021 Not yet recruiting --> Recruiting
- | AB-329 / Baoyuan Biopharma
Enrollment open, Trial initiation date, Combination therapy, Metastases: DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 7, 2018
P1, N=118, Recruiting, Sponsor: Daiichi Sankyo, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Jan 2018 --> Dec 2017
- | AB-329 / Baoyuan Biopharma
Trial initiation date, Combination therapy, Metastases: DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Dec 5, 2017
P1, N=118, Not yet recruiting, Sponsor: Daiichi Sankyo, Inc.
Not yet recruiting --> Recruiting | Initiation date: Jan 2018 --> Dec 2017 Initiation date: Oct 2017 --> Jan 2018
- | AB-329 / Baoyuan Biopharma
New P1 trial, Combination therapy, Metastases: DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Aug 21, 2017
P1, N=118, Not yet recruiting, Sponsor: Daiichi Sankyo, Inc.