- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion, Combination therapy, Metastases: AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer (clinicaltrials.gov) - Aug 21, 2024 P1, N=76, Completed, Outcomes with current treatments after progression on platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitors remain poor, highlighting an unmet medical need in the metastatic NSCLC 1L+ population. Active, not recruiting --> Completed
- |||||||||| danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Trial primary completion date: PEMDA-HN: Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC (clinicaltrials.gov) - Apr 9, 2024 P2, N=81, Recruiting, The SCORES study in recurrent and/or metastatic (RM) HNSCC patients, na Trial completion date: Aug 2025 --> May 2026 | Trial primary completion date: Sep 2024 --> May 2025
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Combination therapy, Metastases: AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer (clinicaltrials.gov) - Mar 17, 2024 P1, N=76, Active, not recruiting, Durvalumab-ceralasertib is under further investigation in immunotherapy-refractory NSCLC.ClinicalTrials.gov identifier: NCT03334617. Trial completion date: Dec 2025 --> Jun 2024
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Trial primary completion date, Mismatch repair, IO biomarker, Metastases: NCI-2018-01296: Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer (clinicaltrials.gov) - Mar 2, 2024 P2, N=39, Active, not recruiting, Trial completion date: May 2023 --> Mar 2026 Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics, AZD5069 / AstraZeneca
Phase classification, Trial completion date, Combination therapy, Monotherapy, Metastases: Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck (clinicaltrials.gov) - Jan 9, 2024 P1/2, N=340, Active, not recruiting, Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025 Phase classification: P1b/2 --> P1/2 | Trial completion date: Dec 2023 --> Mar 2025
- |||||||||| Biomarker, Phase classification, Trial completion date: BISCAY: Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Dec 10, 2023
P1, N=156, Active, not recruiting, Phase classification: P1b/2 --> P1/2 | Trial completion date: Dec 2023 --> Mar 2025 Phase classification: P1b --> P1 | Trial completion date: Sep 2023 --> Jun 2024
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Trial initiation date, Trial primary completion date, Monotherapy: Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML (clinicaltrials.gov) - Nov 30, 2023 P1, N=24, Not yet recruiting, Phase classification: P1b --> P1 | Trial completion date: Sep 2023 --> Jun 2024 Trial completion date: Dec 2027 --> Mar 2028 | Initiation date: Oct 2023 --> Jan 2024 | Trial primary completion date: Mar 2025 --> Jun 2025
- |||||||||| danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial initiation date: PEMDA-HN: Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC (clinicaltrials.gov) - Nov 30, 2023 P2, N=81, Recruiting, Trial completion date: Dec 2027 --> Mar 2028 | Initiation date: Oct 2023 --> Jan 2024 | Trial primary completion date: Mar 2025 --> Jun 2025 Initiation date: Dec 2023 --> May 2023
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Enrollment open, Monotherapy: Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML (clinicaltrials.gov) - Oct 4, 2023 P1, N=24, Recruiting, Multiplatform immune profiling suggested improved MPR rates in the durvalumab plus oleclumab and durvalumab plus monalizumab arms were associated with enhanced effector immune infiltration of tumors, interferon responses and markers of tertiary lymphoid structure formation, and systemic functional immune-cell activation. Not yet recruiting --> Recruiting
- |||||||||| Imfinzi (durvalumab) / AstraZeneca
Enrollment change, Trial completion date, Trial primary completion date, Metastases: MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) - Jun 1, 2023 P1, N=175, Active, not recruiting, The SCORES Study (ESMO 2018) in RM HNSCC patients na N=258 --> 175 | Trial completion date: Mar 2026 --> May 2023 | Trial primary completion date: Mar 2026 --> May 2023
- |||||||||| danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Enrollment open: PEMDA-HN: Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC (clinicaltrials.gov) - May 24, 2023 P2, N=81, Recruiting, N=258 --> 175 | Trial completion date: Mar 2026 --> May 2023 | Trial primary completion date: Mar 2026 --> May 2023 Not yet recruiting --> Recruiting
- |||||||||| Biomarker, Trial completion date: BISCAY: Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Mar 17, 2023
P1b, N=156, Active, not recruiting, Not yet recruiting --> Recruiting Trial completion date: Mar 2023 --> Sep 2023
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Trial primary completion date, Mismatch repair, IO biomarker, Metastases: NCI-2018-01296: Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer (clinicaltrials.gov) - Mar 14, 2023 P2, N=53, Active, not recruiting, Trial completion date: Mar 2023 --> Sep 2023 Trial completion date: Mar 2023 --> Apr 2024 | Trial primary completion date: Mar 2023 --> Apr 2024
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Combination therapy, IO biomarker, Metastases: AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer (clinicaltrials.gov) - Nov 3, 2022 P1, N=76, Active, not recruiting, Trial completion date: Jan 2026 --> Feb 2025 | Trial primary completion date: Jan 2026 --> Feb 2025 Trial completion date: Dec 2022 --> Dec 2025
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca
P1 data, PK/PD data, Clinical Trial,Phase I, Journal, Combination therapy, Monotherapy, PD(L)-1 Biomarker: Safety, tolerability, pharmacokinetics and preliminary antitumour activity of an antisense oligonucleotide targeting STAT3 (danvatirsen) as monotherapy and in combination with durvalumab in Japanese patients with advanced solid malignancies: a phase 1 study. (Pubmed Central) - Oct 28, 2022 P1 Danvatirsen was well tolerated by Japanese patients with advanced solid tumours as monotherapy and combined with durvalumab. No new safety signals arose.
- |||||||||| Biomarker, Trial completion date: BISCAY: Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Oct 18, 2022
P1b, N=156, Active, not recruiting, No new safety signals arose. Trial completion date: Sep 2022 --> Mar 2023
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics, AZD5069 / AstraZeneca
Trial completion date, Combination therapy, Monotherapy, IO biomarker, Metastases: Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck (clinicaltrials.gov) - Oct 7, 2022 P1b/2, N=340, Active, not recruiting, Trial completion date: Sep 2022 --> Mar 2023 Trial completion date: Sep 2022 --> Dec 2023
- |||||||||| HUDSON: An Open-Label, Multi-Drug, Biomarker-Directed Phase 2 Study in NSCLC Patients Who Progressed on Anti-PD-(L)1 Therapy (Hall C7) - Jun 24, 2022 - Abstract #IASLCWCLC2022IASLC_WCLC_817;
P2 Here we present mature efficacy and safety results for the initial combinations - durvalumab plus: olaparib (PARP inhibitor; Module 1), danvatirsen (STAT3 inhibitor; Module 2), ceralasertib (ATR inhibitor; Module 3), and oleclumab (anti-CD73 antibody; Module 5). Durvalumab plus ceralasertib demonstrated a promising efficacy signal, with a tolerable safety profile, in patients with advanced/metastatic NSCLC following failure of anti-PD-1/PD-L1-containing immunotherapy and ≥1 platinum-doublet regimen.
- |||||||||| Biomarker, Trial completion date: BISCAY: Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (clinicaltrials.gov) - May 20, 2022
P1b, N=156, Active, not recruiting, Trial completion date: Aug 2024 --> Jan 2026 | Trial primary completion date: Aug 2024 --> Jan 2026 Trial completion date: Feb 2022 --> Sep 2022
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Trial primary completion date, Mismatch repair, IO biomarker, Metastases: NCI-2018-01296: Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer (clinicaltrials.gov) - Apr 29, 2022 P2, N=53, Active, not recruiting, Trial completion date: Jan 2024 --> Mar 2026 | Trial primary completion date: Jan 2024 --> Mar 2026 Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Trial primary completion date, Mismatch repair, IO biomarker, Metastases: NCI-2018-01296: Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer (clinicaltrials.gov) - Dec 27, 2021 P2, N=53, Active, not recruiting, The primary endpoint was met, with durvalumab plus tremelimumab/danvatirsen generally well tolerated in patients with relapsed/refractory DLBCL; however, antitumor activity was limited. Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Mar 2022
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Combination therapy, IO biomarker, Metastases: AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer (clinicaltrials.gov) - Dec 7, 2021 P1, N=76, Active, not recruiting, Collectively, these data provide rationale for testing this combination in the clinic. Trial completion date: Dec 2021 --> Dec 2022
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics, AZD5069 / AstraZeneca
Trial completion date, Combination therapy, Monotherapy, IO biomarker, Metastases: Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck (clinicaltrials.gov) - Nov 23, 2021 P1b/2, N=340, Active, not recruiting, Trial completion date: Dec 2021 --> Dec 2022 Trial completion date: Sep 2021 --> Sep 2022
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, danvatirsen (AZD9150) / AstraZeneca
A Transgenic Murine Model Expressing Hyperactive STAT3 Recapitulates the Features of MDS/AML (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4984; FDA approved therapies such as the recently approved Bcl-2 inhibitor venetoclax, FLT3 inhibitors, among others, have moved the field forward in newly diagnosed MDS/AML...We have successfully demonstrated that a selective antisense oligonucleotide inhibitor of STAT3, Danvatirsen, is rapidly incorporated into MDS/AML HSPCs and induces selective apoptosis and downregulation of STAT3 in these cells in comparison with healthy control HSPCs...Through the generation of a STAT3C-vavCre mouse model, that recapitulates the features of MDS/AML, we aim to further our understanding of the molecular mechanisms and pathways that play an important role in MDS to AML transformation and will help us identify downstream mediators of this event that can be therapeutically targeted. We would also like to use this murine model as an ideal substrate for preclinical studies of STAT3 targeting therapies in hematologic malignancies such as previously reported antisense inhibitors of STAT3 and STAT3 degraders.
- |||||||||| danvatirsen (AZD9150) / AstraZeneca
Journal: Should We Strive to Make Science Bias-Free? A Philosophical Assessment of the Reproducibility Crisis. (Pubmed Central) - Nov 2, 2021 This conclusion sets the stage for an assessment of the view that evidential relations in science are inherently value-laden, a view championed by Heather Douglas and Kevin Elliott. I argue, in response to Douglas and Elliott, and as motivated by the meta-scientific resistance scientists harbour to a publication bias, that if we advocate the value-ladenness of science the result would be a deepening of the reproducibility crisis.
- |||||||||| danvatirsen (AZD9150) / AstraZeneca
Journal: Research on bilingualism as discovery science. (Pubmed Central) - Oct 29, 2021 We propose and illustrate by drawing from previous and contemporary examples within brain and cognitive sciences, that this necessitates exploring the neural bases of bilingual phenotypes:the adaptive variety induced through the interplay of biology and culture. We identify the conceptual and methodological prerequisites for such exploration and briefly allude to the publication practices that afford it as a community practice and to the risk of allowing methodological prescriptions, rather than discovery, to dominate the research endeavor.
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