Phase I, First-in-Human Study of the Probody Therapeutic CX-2029 in Adults with Advanced Solid Tumor Malignancies

2021 ◽  
Author(s):  
Melissa Johnson ◽  
Anthony El-Khoueiry ◽  
Navid Hafez ◽  
Nehal Lakhani ◽  
Hirva Mamdani ◽  
...  
Keyword(s):  
Phase I ◽  
Solid Tumor ◽  
Human Study ◽  
Advanced Solid Tumor

A phase I first-in-human study of REGN910, a fully human and selective angiopoietin-2 monoclonal antibody, in patients with advanced solid tumor malignancies.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. TPS159-TPS159 ◽  
Author(s):  
K. P. Papadopoulos ◽  
N. G. Chau ◽  
A. Patnaik ◽  
L. Adriaens ◽  
A. S. Lalani ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Phase I ◽  
Solid Tumor ◽  
Human Study ◽  
Advanced Solid Tumor ◽  
Angiopoietin 2

A phase I study of intravenous artesunate in patients with advanced solid tumor malignancies

2018 ◽  
Vol 81 (3) ◽  
pp. 587-596 ◽  
Author(s):  
John F. Deeken ◽  
Hongkun Wang ◽  
Marion Hartley ◽  
Amrita K. Cheema ◽  
Brandon Smaglo ◽  
...  
Keyword(s):  
Phase I ◽  
Solid Tumor ◽  
Phase I Study ◽  
Advanced Solid Tumor

scholarly journals A phase I study of liposomal-encapsulated docetaxel (LE-DT) in patients with advanced solid tumor malignancies

2012 ◽  
Vol 71 (3) ◽  
pp. 627-633 ◽  
Author(s):  
John F. Deeken ◽  
Rebecca Slack ◽  
Glen J. Weiss ◽  
Ramesh K. Ramanathan ◽  
Michael J. Pishvaian ◽  
...  
Keyword(s):  
Phase I ◽  
Solid Tumor ◽  
Phase I Study ◽  
Advanced Solid Tumor

scholarly journals Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients

2015 ◽  
Vol 75 (3) ◽  
pp. 579-586 ◽  
Author(s):  
T. C. Chang ◽  
H. S. Shiah ◽  
C. H. Yang ◽  
K. H. Yeh ◽  
A. L. Cheng ◽  
...  
Keyword(s):  
Phase I ◽  
Solid Tumor ◽  
Phase I Study ◽  
Advanced Solid Tumor ◽  
Tumor Patients ◽  
Nanoliposomal Irinotecan

A phase I study of the CDK4/6 inhibitor, palbociclib plus 5-fluorouracil (5FU) in patients with advanced solid tumor malignancies (NCT01522989).

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 2589-2589 ◽  
Author(s):  
Michael J. Pishvaian ◽  
Hongkun Wang ◽  
Brandon George Smaglo ◽  
Jennifer Gao ◽  
Laura Macke ◽  
...  
Keyword(s):  
Phase I ◽  
Solid Tumor ◽  
Phase I Study ◽  
Advanced Solid Tumor

BPI-9016M, a novel c-Met inhibitor, in pretreated advanced solid tumor: Results from a first-in-human, phase I, dose-escalation study.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e21108-e21108
Author(s):  
Xingsheng Hu ◽  
Xin Zheng ◽  
Hongnan Mo ◽  
Xinge Cui ◽  
Lieming Ding ◽  
...  
Keyword(s):  
Phase I ◽  
Dose Escalation ◽  
Solid Tumor ◽  
Advanced Solid Tumor ◽  
Dose Escalation Study ◽  
Met Inhibitor

Safety and efficacy of TQ-B3525, a novel and selective oral PI3K α/δ inhibitor, in Chinese patients with advanced malignancies: A phase I dose-escalation and expansion trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 8058-8058
Author(s):  
Huaqing Wang ◽  
Wenqi Jiang ◽  
Su Li ◽  
Yu Wang ◽  
Peng Sun ◽  
...  
Keyword(s):  
Antitumor Activity ◽  
Phase I ◽  
Dose Escalation ◽  
Solid Tumor ◽  
Geometric Mean ◽  
Chinese Patients ◽  
Advanced Solid Tumor ◽  
Advanced Malignancies ◽  
Anti Cancer ◽  
Grade 3

8058 Background: TQ-B3525 is a novel and selective oral PI3K α/δ inhibitor with activity 41 and 138 folds higher than Buparlisib against PI3K α and PI3K δ in pre-clinical research. This Phase I study (NCT03510767) assessed the safety, tolerability, pharmacokinetics and antitumor activity of TQ-B3525 in Chinese patients with advanced malignancies. Methods: Patients with relapsed or refractory (R/R) lymphoma who have experienced at least two prior systemic anti-cancer treatments, and advanced solid tumor who have failed standard anti-cancer treatment, were enrolled. TQ-B3525 was administered orally from 2mg, 5mg, 10mg, 20mg once daily (qd) to 10mg, 20mg twice daily (bid). DLT was observed in the first cycle (28 days) of dose-escalation phase. Dose-expansion phase started at the dose level which objective response occurs. Results: Between June 2018 and December 2019, a total of 40 patients were enrolled, Including 27 patients with R/R lymphoma and 13 patients with advanced solid tumor. Three DLTs (both grade 3 hyperglycemia) were observed: two in the 20mg bid dose cohort and one in the 10mg bid. The common AEs of all grades were hyperglycemia (65.0%), glycosylated hemoglobin increased (35.0%) and diarrhea (32.5%). Grade 3 or 4 treatment-related AEs occurred in 11 patients (27.5%), with the most common one also being hyperglycemia (10.0%). TQ-B3525 was rapidly absorbed (Tmax: 1-2 h) and moderately eliminated (T1/2: 10-12 h). At steady state, the geometric mean AUC0-24 and Ctrough of TQ-B3525 at 20mg qd were 1060.7 ± 198.6 h*ng/mL and 23.4 ± 9.5 ng/mL, which was above IC50 (4.2 ng/ml). 23 lymphoma patients were evaluable for clinical response per 2014 Lugano Classification. The overall response rate (ORR) was 60.9% (95% CI, 38.5-80.2). The ORR at ≥10mg qd was 70.0% (14/20, [95% CI, 49.9-90.1]). For R/R FL, the ORR was 72.7% (8/11, [95% CI, 46.4-99.1]). At data cut-off (2nd February, 2020), the median PFS for lymphoma was not reached (events rate: 33.3%). The longest duration of response at data cutoff was 11.8 months in a patient with FL. Conclusions: TQ-B3525 is well-tolerated in Chinese patients with advanced malignancies, and demonstrated high promising antitumor activity in R/R lymphoma patients. Recommended phase II dose was established at 20mg qd. A single-arm phase 2 trial of TQ-B3525 in patients with R/R FL is currently underway. Clinical trial information: NCT03510767 .

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