A5103080558- Cancer Immunotherapy and Biomarkers
- Chronic Lymphocytic Leukemia Research
- HER2/EGFR in Cancer Research
- Colorectal Cancer Treatments and Studies
- Biosimilars and Bioanalytical Methods
- Lung Cancer Treatments and Mutations
- Cancer Treatment and Pharmacology
- Pancreatic and Hepatic Oncology Research
- Lymphoma Diagnosis and Treatment
- Advanced Breast Cancer Therapies
- Radiopharmaceutical Chemistry and Applications
- Biochemical and Molecular Research
- Pharmacogenetics and Drug Metabolism
- Thyroid Cancer Diagnosis and Treatment
- Immune Cell Function and Interaction
- Advanced NMR Techniques and Applications
- Cancer therapeutics and mechanisms
- Monoclonal and Polyclonal Antibodies Research
- Neuroblastoma Research and Treatments
- Renal cell carcinoma treatment
- PI3K/AKT/mTOR signaling in cancer
- Thyroid Disorders and Treatments
- Cancer Diagnosis and Treatment
- Growth Hormone and Insulin-like Growth Factors
- HIV/AIDS drug development and treatment
Bayer (United States)
2016-2025
NorthBay Healthcare
2016
Abstract Purpose: Copanlisib in combination with immune checkpoint inhibitors (ICIs) demonstrated synergy and favorable anti-tumor responses preclinical models. This study evaluated copanlisib plus nivolumab adults advanced solid tumors. Patients Methods: In this Phase Ib, non-randomized, open-label, dose-escalation study, patients received intravenous 240 mg (day 15 of cycle 1 days subsequent cycles) (45 or 60 on 1, 8, each cycle) 28-day cycles. The primary objective was to determine the...
<p>Distribution of individual copanlisib clearance values in the present study and Phase II monotherapy study, CHRONOS-1</p>
<p>Exploratory biomarker endpoints. Data are shown for change from baseline in the median proportion of MDSCs over time (<b>A</b>), percentage CD45RA<sup>−</sup> (CD3<sup>+</sup>/CD8<sup>+</sup>) cells and clearance at by BOR (<b>B</b>), circulating IL-2 levels (<b>C</b>). BOR, best overall response; C, cycle; D, day; NE, not evaluable.</p>
<p>Best overall response per RECIST version 1.1 (full analysis set)</p>
<p>Representativeness of study participants</p>
<p>Secondary efficacy endpoints. Data are shown for progression-free survival (<b>A</b>) and OS (<b>B</b>) as assessed locally by study investigators (full analysis set). <sup>a</sup>95% CI based on the Greenwood formula. PFS, survival.</p>
<p>Prediction-corrected visual predictive checks of the final copanlisib population PK model in describing present study</p>
<p>Response and duration of treatment (<b>A</b>) percentage change in target lesions (<b>B</b>; full analysis set).</p>
<p>Prediction‐corrected visual predictive checks of the nivolumab population PK model in describing present study</p>
<p>Criteria for defining dose-limiting toxicities</p>
<p>Patient demographics and baseline cancer characteristics</p>
<div>AbstractPurpose:<p>Copanlisib in combination with immune checkpoint inhibitors demonstrated synergy and favorable antitumor responses preclinical models. This study evaluated copanlisib plus nivolumab adults advanced solid tumors.</p>Patients Methods:<p>In this phase Ib, nonrandomized, open-label, dose-escalation study, patients received intravenous 240 mg (day 15 of cycle 1 days subsequent cycles) (45 or 60 on 1, 8, each cycle) 28-day cycles. The primary...
<p>Distribution of individual copanlisib AUC[0–168]nd values across dose levels</p>
<p>Biomarker sampling time points</p>
<p>Summary of patient safety outcomes (full analysis set)</p>
Background: BAY 1862864 is an α-particle emitting 227Th-labeled CD22-targeting antibody. This first-in-human dose-escalation phase I study evaluated in patients with CD22-positive relapsed/refractory B cell non-Hodgkin lymphoma (R/R-NHL). Materials and Methods: intravenous injections were administered at the starting 227Th radioactivity dose of 1.5 MBq (2 or 10 mg antibody), escalated ∼1.5 increments (10 antibody) until maximum tolerated (MTD) was reported. The primary objective to determine...
Darolutamide is a second-generation androgen receptor inhibitor approved for the treatment of nonmetastatic castration-resistant prostate cancer at dosage 600 mg orally twice daily.We aimed to fully characterize pharmacokinetic profile darolutamide, its diastereomers, and main active metabolite, keto-darolutamide.Single-dose multiple-dose pharmacokinetics 14C-labeled non-labeled darolutamide were evaluated in healthy subjects patients with hepatic or renal impairment.Following oral tablet...
Regorafenib 160 mg orally once daily (QD) 3 weeks on/1 week off is approved in colorectal cancer, gastrointestinal stromal tumors and hepatocellular carcinoma. We established the safety pharmacokinetics (PK) of regorafenib combined with cetuximab advanced refractory solid tumors. This was a phase 1, open‐label, dose‐escalation study (NCT01973868) patients advanced/metastatic who progressed after standard therapy. administered at various dose levels QD continuously or intermittently (3 off)...
Sorafenib is an oral multikinase inhibitor approved for the treatment of differentiated thyroid carcinoma (DTC), renal cell carcinoma, and hepatocellular carcinoma. In phase III DECISION trial in patients with DTC, sorafenib exposure incidence some adverse events (AEs) were higher than previous trials; therefore, we analyzed exposure-response relationships, including progression-free survival (PFS) selected AEs DTC. A novel, stratified prediction-corrected visual predictive check (pc-VPC)...
Background: Patients receiving the multikinase inhibitor sorafenib for locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine often receive concomitant levothyroxine thyrotropin (TSH) suppression. In Phase 3 DTC trial (DECISION), exposure was approximately twofold higher than that observed in other cancers. This study assessed pharmacokinetics without and with examine whether a interaction levothyroxine-induced subclinical...