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20 Diseases |  |
7 Trials |
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7 Trials |  |
220 News |  |
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- || Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics, AZD5069 / AstraZeneca
Trial completion date, Monotherapy, IO biomarker: Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck (clinicaltrials.gov) - Apr 28, 2025
P1/2, N=340, Active, not recruiting, Sponsor: AstraZeneca
Trial completion date: Mar 2025 --> Aug 2025
- || Review, Journal: STAT3 Signaling Pathway in Health and Disease. (Pubmed Central) - Apr 1, 2025
By integrating molecular mechanisms, disease pathology, and emerging therapeutic interventions, this review fills a critical knowledge gap in STAT3-targeted therapy. Our insights into STAT3 signaling crosstalk, epigenetic regulation, and resistance mechanisms offer a foundation for developing next-generation STAT3 inhibitors with greater clinical efficacy and translational potential.
- danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
ASO-mediated STAT3 knockdown relieves immunosuppression sensitizing tumors to immunotherapies (Section 38; Poster Board No: 15) - Mar 25, 2025 - Abstract #AACR2025AACR_4440;
P2
Similar results were obtained in the EMT6 model. In conclusion, these data showed that ASO-mediated STAT3 KD relieves immunosuppression thereby sensitizing tumors to immunotherapies.
- || Biomarker, Trial completion date, Trial primary completion date, IO biomarker: HUDSON: Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (clinicaltrials.gov) - Dec 27, 2024
P2, N=531, Active, not recruiting, Sponsor: AstraZeneca
In conclusion, these data showed that ASO-mediated STAT3 KD relieves immunosuppression thereby sensitizing tumors to immunotherapies. Trial completion date: Sep 2024 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2026
- | Biomarker, Trial completion date: BISCAY: Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Dec 12, 2024
P1, N=117, Active, not recruiting, Sponsor: AstraZeneca
Trial completion date: Sep 2024 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2026 Trial completion date: Jun 2024 --> Mar 2025
- Venclexta (venetoclax) / Roche, AbbVie, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
A Phase 1 Study Investigating the Safety and Efficacy of Danvatirsen As Monotherapy Followed By Combination with Venetoclax in Patients with Relapsed/Refractory MDS and AML (Halls G-H (San Diego Convention Center)) - Nov 21, 2024 - Abstract #ASH2024ASH_7220;
P1
Samples for biomarker analysis are collected and being analyzed. Updated data will be reported at the ASH Annual Meeting.
- A Systematic Literature Review (SLR) of the Clinical Efficacy and Safety Evidence Associated With Treatments for Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Progressed on Prior Therapies () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1645;
Discontinuations due to adverse events (AEs; n=14) ranged from 0% (atezolizumab) to 40% of patients (nintedanib+docetaxel)... 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.
- ||| 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, Sponsor: AstraZeneca
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
- Keytruda (pembrolizumab) / Merck (MSD), danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
PEMDA-HN, an open-label, phase II, randomized controlled study of danvatirsen plus pembrolizumab compared to pembrolizumab alone in first-line recurrent and/or metastatic head and neck squamous cell carcinoma (RM HNSCC). (Hall A; Poster Bd #: 429a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3563;
P2
Active, not recruiting --> Completed The SCORES study in recurrent and/or metastatic (RM) HNSCC patients, na
- || 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, Sponsor: Flamingo Therapeutics NV
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
Biomarker, P2 data, Clinical Trial,Phase II, Journal, PARP Biomarker, PD(L)-1 Biomarker, IO biomarker, Metastases: Biomarker-directed targeted therapy plus durvalumab in advanced non-small-cell lung cancer: a phase 2 umbrella trial. (Pubmed Central) - Mar 25, 2024
P2
Biomarker analyses suggested that anti-PD-L1/ATR inhibition induced immune changes that reinvigorated antitumor immunity. Durvalumab-ceralasertib is under further investigation in immunotherapy-refractory NSCLC.ClinicalTrials.gov identifier: NCT03334617.
- | 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, Sponsor: AstraZeneca
Durvalumab-ceralasertib is under further investigation in immunotherapy-refractory NSCLC.ClinicalTrials.gov identifier: NCT03334617. Trial completion date: Dec 2025 --> Jun 2024
- | Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Metastases: MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) - Mar 2, 2024
P1, N=175, Active, not recruiting, Sponsor: AstraZeneca
Trial completion date: Dec 2025 --> Jun 2024 Trial completion date: May 2023 --> Mar 2026
- | Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Trial primary completion date, Mismatch repair, IO biomarker: 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, Sponsor: M.D. Anderson Cancer Center
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, Monotherapy, IO biomarker: 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, Sponsor: AstraZeneca
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, Sponsor: AstraZeneca
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, Sponsor: Montefiore Medical Center
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, Sponsor: Flamingo Therapeutics NV
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
- || danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial initiation date: PEMDA-HN: Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC (clinicaltrials.gov) - Nov 27, 2023
P2, N=81, Recruiting, Sponsor: Flamingo Therapeutics NV
Initiation date: Dec 2023 --> May 2023 Initiation date: Sep 2023 --> Dec 2023
- || Imfinzi (durvalumab) / AstraZeneca
P2 data, Journal, PD(L)-1 Biomarker, IO biomarker, Immuno-oncology: Neoadjuvant Durvalumab Alone or Combined with Novel Immuno-Oncology Agents in Resectable Lung Cancer: The Phase 2 NeoCOAST Platform Trial. (Pubmed Central) - Nov 3, 2023
Safety profiles for the combinations were similar to that of durvalumab alone. 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.
- | 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, Sponsor: Montefiore Medical Center
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
- ||| Biomarker, Enrollment closed, IO biomarker: HUDSON: Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (clinicaltrials.gov) - Sep 11, 2023
P2, N=531, Active, not recruiting, Sponsor: AstraZeneca
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics, Calquence (acalabrutinib) / AstraZeneca
Biomarker, P1 data, Clinical Trial,Phase I, Journal, IO biomarker, Circulating tumor DNA: Phase 1 Study of Acalabrutinib Plus Danvatirsen (AZD9150) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma Including Circulating Tumor DNA Biomarker Assessment. (Pubmed Central) - Sep 4, 2023
Targeting both STAT3 and BTK in combination is safe and tolerable but efficacy is limited in R/R DLBCL. Results support evaluation of circulating tumor DNA as a biomarker for clinical response.
- || danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial initiation date: PEMDA-HN: Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC (clinicaltrials.gov) - Aug 21, 2023
P2, N=81, Recruiting, Sponsor: Flamingo Therapeutics NV
Results support evaluation of circulating tumor DNA as a biomarker for clinical response. Initiation date: Jun 2023 --> Sep 2023
- || Biomarker, Trial completion date, Trial primary completion date, IO biomarker: HUDSON: Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (clinicaltrials.gov) - Aug 14, 2023
P2, N=570, Recruiting, Sponsor: AstraZeneca
Initiation date: Jun 2023 --> Sep 2023 Trial completion date: Feb 2025 --> Sep 2024 | Trial primary completion date: Feb 2025 --> Sep 2024
- | Venclexta (venetoclax) / Roche, AbbVie, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
New P1 trial, Monotherapy: Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML (clinicaltrials.gov) - Aug 14, 2023
P1, N=24, Not yet recruiting, Sponsor: Montefiore Medical Center
- Keytruda (pembrolizumab) / Merck (MSD), danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
PEMDA-HN, an open-label, phase II, randomized controlled study of danvatirsen plus pembrolizumab compared to pembrolizumab alone in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2489;
P2
Trial completion date: Feb 2025 --> Sep 2024 | Trial primary completion date: Feb 2025 --> Sep 2024 The SCORES Study (ESMO 2018) in RM HNSCC patients na
- || 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, Sponsor: AstraZeneca
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, Sponsor: Flamingo Therapeutics NV
N=258 --> 175 | Trial completion date: Mar 2026 --> May 2023 | Trial primary completion date: Mar 2026 --> May 2023 Not yet recruiting --> Recruiting
- | danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
New P2 trial: PEMDA-HN: Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC (clinicaltrials.gov) - Apr 18, 2023
P2, N=81, Not yet recruiting, Sponsor: Flamingo Therapeutics NV
- | 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, Sponsor: AstraZeneca
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: 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, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Mar 2023 --> Sep 2023 Trial completion date: Mar 2023 --> Apr 2024 | Trial primary completion date: Mar 2023 --> Apr 2024
- || Biomarker, Trial completion date, Trial primary completion date, IO biomarker: HUDSON: Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (clinicaltrials.gov) - Mar 10, 2023
P2, N=570, Recruiting, Sponsor: AstraZeneca
Trial completion date: Mar 2023 --> Apr 2024 | Trial primary completion date: Mar 2023 --> Apr 2024 Trial completion date: Jan 2026 --> Feb 2025 | Trial primary completion date: Jan 2026 --> Feb 2025
- | 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, Sponsor: AstraZeneca
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, Sponsor: AstraZeneca
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, Monotherapy, IO biomarker: 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, Sponsor: AstraZeneca
Trial completion date: Sep 2022 --> Mar 2023 Trial completion date: Sep 2022 --> Dec 2023
- Imfinzi (durvalumab) / AstraZeneca
Platform study of neoadjuvant durvalumab (D) alone or combined with novel agents in patients (pts) with resectable, early-stage non-small cell lung cancer (NSCLC): Pharmacodynamic correlates and circulating tumor DNA (ctDNA) dynamics in the NeoCOAST study (7.3.O - Orléans Auditorium) - Jul 25, 2022 - Abstract #ESMO2022ESMO_1711;
P2
Association of tumor mutational burden and additional biomarkers with clinical outcomes will be reported. Conclusions Single cycle of D+O and D+M resulted in greater intra-tumoral immunomodulation than D alone.
- 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, Trial primary completion date, IO biomarker: HUDSON: Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (clinicaltrials.gov) - May 25, 2022
P2, N=530, Recruiting, Sponsor: AstraZeneca
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. Trial completion date: Aug 2024 --> Jan 2026 | Trial primary completion date: Aug 2024 --> Jan 2026
- | 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, Sponsor: AstraZeneca
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
Trial completion date, Trial primary completion date, Metastases: MAGELLAN: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (clinicaltrials.gov) - May 5, 2022
P1, N=212, Active, not recruiting, Sponsor: AstraZeneca
Trial completion date: Feb 2022 --> Sep 2022 Trial completion date: Jan 2024 --> Mar 2026 | Trial primary completion date: Jan 2024 --> Mar 2026
- || Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Trial primary completion date, Mismatch repair, IO biomarker: 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, Sponsor: M.D. Anderson Cancer Center
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
- | danvatirsen (AZD9150) / AstraZeneca
Journal: C-X-C motif chemokine ligand 12 (CXCL12)/C-X-C motif chemokine receptor 7(CXCR7) regulates epithelial-mesenchymal transition process and promotes the metastasis of esophageal cancer by activating signal transducer and activator of transcription 3 (STAT3) pathway. (Pubmed Central) - Apr 9, 2022
Inhibition of the STAT3 pathway using AZD9150 weakened the accelerated effects of CXCL12/CXCR7 on the growth and metastasis of esophageal cancer in vitro and in vivo. In conclusion, our research revealed that CXCL12/CXCR7 regulates EMT and other malignant processes by activating the STAT3 pathway to accelerate the growth and metastasis of esophageal cancer.
- Imfinzi (durvalumab) / AstraZeneca
NeoCOAST: open-label, randomized, phase 2, multidrug platform study of neoadjuvant durvalumab alone or combined with novel agents in patients (pts) with resectable, early-stage non-small-cell lung cancer (NSCLC) (Hall B-C, Convention Center) - Mar 9, 2022 - Abstract #AACR2022AACR_2141;
P2
Responses were associated with baseline tumor PD-L1 and CD73 expression levels. Pts with MPR receiving D+O or D+M had peripheral transcriptomic signatures related to immune cell function.
- || Biomarker, Trial completion date, Trial primary completion date, IO biomarker: HUDSON: Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (clinicaltrials.gov) - Mar 4, 2022
P2, N=420, Recruiting, Sponsor: AstraZeneca
Pts with MPR receiving D+O or D+M had peripheral transcriptomic signatures related to immune cell function. Trial completion date: Oct 2023 --> Aug 2024 | Trial primary completion date: Oct 2023 --> Aug 2024
- || tremelimumab (CP-675206) / AstraZeneca, Pfizer, Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca
Clinical, P1 data, Journal, Combination therapy: A Phase 1b Study to Evaluate the Safety and Efficacy of Durvalumab in Combination With Tremelimumab or Danvatirsen in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. (Pubmed Central) - Jan 29, 2022
Trial completion date: Oct 2023 --> Aug 2024 | Trial primary completion date: Oct 2023 --> Aug 2024 The primary endpoint was met, with durvalumab plus tremelimumab/danvatirsen generally well tolerated in patients with relapsed/refractory DLBCL; however, antitumor activity was limited.
- || Imfinzi (durvalumab) / AstraZeneca, danvatirsen (AZD9150) / AstraZeneca, Flamingo Therapeutics
Trial completion date, Trial primary completion date, Mismatch repair, IO biomarker: 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, Sponsor: M.D. Anderson Cancer Center
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
- | danvatirsen (AZD9150) / AstraZeneca
Biomarker, Journal, Combination therapy, Tumor microenvironment, PD(L)-1 Biomarker, IO biomarker: STAT3 antisense oligonucleotide remodels the suppressive tumor microenvironment to enhance immune activation in combination with anti-PD-L1. (Pubmed Central) - Dec 16, 2021
Preclinical data provide evidence that ASO-mediated inhibition of STAT3 in the immune compartment is sufficient to remodel the TME and enhance the activity of checkpoint blockade without direct STAT3 inhibition in tumor cells. Collectively, these data provide rationale for testing this combination in the clinic.
- | 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, Sponsor: AstraZeneca
Collectively, these data provide rationale for testing this combination in the clinic. Trial completion date: Dec 2021 --> Dec 2022