Nashat Gabrail
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View article: Zipalertinib in Patients With Epidermal Growth Factor Receptor Exon 20 Insertion-Positive Non–Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab
Zipalertinib in Patients With Epidermal Growth Factor Receptor Exon 20 Insertion-Positive Non–Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab Open
PURPOSE To evaluate the safety and efficacy of zipalertinib, an irreversible epidermal growth factor receptor (EGFR) inhibitor, in pretreated patients with non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion (ex20ins) mutat…
View article: Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study
Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study Open
PURPOSE Tumor treating fields (TTFields) use alternating electric fields to disrupt cancer cell proliferation. Feasibility of TTFields therapy with gemcitabine/nab-paclitaxel was previously demonstrated in patients with advanced pancreatic…
View article: Table S1 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Table S1 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Representativeness of study participants
View article: Table 2 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Table 2 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Summary of patient safety outcomes (full analysis set)
View article: Figure 1 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Figure 1 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Response and duration of treatment (A) and percentage change in target lesions (B; full analysis set).
View article: Figure S4 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Figure S4 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Distribution of individual copanlisib AUC[0–168]nd values across copanlisib dose levels
View article: Figure S1 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Figure S1 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Prediction-corrected visual predictive checks of the final copanlisib population PK model in describing copanlisib PK in the present study
View article: Table 1 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Table 1 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Patient demographics and baseline cancer characteristics
View article: Figure S3 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Figure S3 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Distribution of individual copanlisib clearance values in the present study and in the Phase II copanlisib monotherapy study, CHRONOS-1
View article: Figure 3 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Figure 3 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Exploratory biomarker endpoints. Data are shown for change from baseline in the median proportion of MDSCs over time (A), percentage of CD45RA− (CD3+/CD8+) cells and clearance at baseline by BOR (B), and circulating IL-2 levels at baseline…
View article: Figure S2 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Figure S2 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Prediction‐corrected visual predictive checks of the nivolumab population PK model in describing nivolumab PK in the present study
View article: Table S3 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Table S3 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Biomarker sampling time points
View article: Table 3 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Table 3 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Best overall response per RECIST version 1.1 (full analysis set)
View article: Table S2 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Table S2 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Criteria for defining dose-limiting toxicities
View article: Figure 2 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Figure 2 from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Secondary efficacy endpoints. Data are shown for progression-free survival (A) and OS (B) as assessed locally by study investigators (full analysis set). a95% CI based on the Greenwood formula. PFS, progression-free survival.
View article: Data from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Data from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Purpose:Copanlisib in combination with immune checkpoint inhibitors demonstrated synergy and favorable antitumor immune responses in preclinical models. This study evaluated copanlisib plus nivolumab in adults with advanced solid tumors.Pa…
View article: A plain language summary of the ASCERTAIN trial: oral decitabine and cedazuridine versus intravenous decitabine for MDS or CMML
A plain language summary of the ASCERTAIN trial: oral decitabine and cedazuridine versus intravenous decitabine for MDS or CMML Open
What is this summary about? This summary describes results from a phase 3 clinical trial called ASCERTAIN.Researchers compared two treatments in people with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML), either …
View article: Phase Ib Trial of Batiraxcept in Combination With Nab-Paclitaxel and Gemcitabine for Previously Untreated Advanced Pancreatic Cancer
Phase Ib Trial of Batiraxcept in Combination With Nab-Paclitaxel and Gemcitabine for Previously Untreated Advanced Pancreatic Cancer Open
PURPOSE Increased anexelekto (AXL) pathway signaling in pancreatic cancer can increase cellular invasion, migration, proliferation, and protumoral infiltration of tumor-associated macrophages and fibroblasts. Batiraxcept acts as a novel de…
View article: Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors
Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors Open
Purpose: Copanlisib in combination with immune checkpoint inhibitors demonstrated synergy and favorable antitumor immune responses in preclinical models. This study evaluated copanlisib plus nivolumab in adults with advanced solid tumors. …
View article: COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC
COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC Open
Treatment options for patients with biliary tract cancer are limited, and the prognosis is poor. CTX-009, a novel bispecific antibody targeting both DLL4 and VEGF-A, has demonstrated antitumor activity in patients with advanced cancers as …
View article: 674 A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3L and in combination with pembrolizumab in 1L recurrent/metastatic HPV16+ head and neck cancer patients
674 A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3L and in combination with pembrolizumab in 1L recurrent/metastatic HPV16+ head and neck cancer patients Open
Background Immuno-STATs are modular T cell engagers engineered to selectively activate tumor-antigen specific CD8+ T cells via targeted delivery of cytokines. CUE-101, the first Immuno-STAT in clinical trials, is composed of a human leukoc…
View article: 750 A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc fusion protein in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers
750 A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc fusion protein in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers Open
Background Immuno-STATs are modular fusion proteins designed for the selective activation of tumor antigen specific CD8+ T cells. CUE-102, the second Immuno-STAT in clinical trials, is composed of a human leukocyte antigen (HLA) complex, H…