This was a multicenter, dose escalation and dose expansion phase 1 study in China. Eligible patients were 18-75 years old with HER2-positive advanced solid tumors who were unable to benefit from standard therapy. DP303c was administered intravenously every 3 weeks, with accelerated titration at ...
This is the first-in-human study of novel anti-angiopoietin-2 (Ang-2) monoclonal antibody LY3127804 as monotherapy and in combination with ramucirumab in advanced solid tumours.Patients received intravenous LY3127804 monotherapy (4, 8, 12, 16, 20 and 27mg/kg) in part A; LY3127804 (8, 12...
BrianCreese,PrincipalConsultant,KendlePtyLimited TraditionalFIHStudies •Usuallyinvolvestestingasingledrugproductcandidate,selectedafterextensivepreclinicaltesting•Usuallyconductedinhealthyvolunteers•Ascendingdosestudydesign•Standardpreclinicaltoxicologypackage(“INDenablingstudies”)–includingrepeated-dosetoxicitystudies...
PD06-02INITIAL 90-DAY SAFETY FINDINGS FROM A FIRST-IN-HUMAN STUDY OF ADAM: AN INNOVATIVE HYDROGEL DESIGNED FOR MALE CONTRACEPTION doi:10.1097/01.JU.0001109764.27496.08.02Wolters KluwerThe Journal of UrologyNathan LawrentschukPeter ChinEric Chung...
38 -- 38:29 App What Matters for On-Policy Deep Actor-Critic Methods? A Large-Scale Study 43 -- 34:26 App Drug Development in the Pediatric Population with Dr. Anne Zajicek 191 -- 10:33 App 【woody魔术系列1】The Human Scale人体天平魔术by woody aragon浏览...
In the present study, the promising efficacy of QL1706 may be independent of the expression of PD-1, since patients with CPS < 1 also showed a relatively high response. However, due to the small sample size, further clinical trials with a larger sample size are needed to confirm this...
A Phase 1 study was initiated to evaluate the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of margetuximab in patients with HER2-overexpressing carcinomas. Patients and methods Patients with HER2-positive breast or gastric cancer, or other carcinomas that ...
This first-in-human, phase I study aimed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of SHR-2004 in healthy Chinese subjects. Methods: This single-center, randomized, double-blind, dose-escalation, placebo-controlled study (NCT05369767; Figure...
We report initial data from a first-in-human study evaluating FS118 in patients with advanced cancer and resistance to PD-(L)1 therapy. Methods The ongoing Phase I FIH study ( NCT03440437 ) is being conducted to evaluate safety, tolerability, immunogenicity, PK/PD and clinical activity of ...
2017. A first-in-human study of the novel HIV-fusion inhibitor C34-PEG4-Chol. Sci Rep 7:9447. https://doi.org/10.1038/s41598-017-09230-0.