These preclinical data support clinical investigation of KO-2806 alone and in combination therapy.Methods:FIT-001 is a first-in-human, multicenter, open-label clinical trial that will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics (Pd), and preliminary antitumor activity of KO-...
Immatics N.V. recently announced the initiation of a Phase 1 clinical trial with its T cell engaging receptor (TCER) IMA401 for patients with recurrent and/or refractory solid tumors. IMA401 is the most advanced product candidate from Immatics’ TCR Bispecific pipelin...
Codexis, Inc. recently announced top-line results from its Phase 1a single ascending-dose study in healthy volunteers with CDX-6114, its orally administered enzyme candidate for the potential treatment of the metabolic disorder phenylketonuria (PKU). All of the defined study endpoints were met. The...
fluorouracil14. A previous single-center clinical trial (NCT03159819) indicated that CT041 was well-tolerated and could be a promising therapy for patients with gastric and pancreatic cancers15. Therefore, we initiated an open-label, multicenter, single-arm, dose-escalation/de-escalation and dose-e...
To test the first of these hypotheses in a controlled setting, we have initiated a phase 1 clinical trial of IUHCT in fetuses with alpha thalassemia major (ATM), who already require a fetal intervention (in utero transfusions (IUT)) to survive the pregnancy. We present interim results from...
Potential cytochrome P-450 (CYP) drug-drug interactions in adults with metastatic solid tumors and their effect on eligibility for Phase I clinical trials were characterized.This study included adult patients with metastatic solid tumors seen by a medical oncologist from January 2008 through July 2011...
7). We conducted a phase 1/2a clinical trial to evaluate the safety, pharmacokinetics and antiviral activity of up to six monthly infusions of PGT121, PGDM1400 and VRC07-523LS in PLWH. Results Study design and safety Part 1 of this phase 1/2a study was a single-center, open-label ...
The results of this randomized clinical trial suggest that supplementation with live bacterial products may augment the activity of CPIs. Perhaps more importantly, the efficacy analyses highlighted a significant improvement in PFS with the addition of CBM588 to nivolumab–ipilimumab. Although this must ...
To our knowledge, this first-in-human dose-optimization study is the first clinical trial reporting the results of an mRNA therapeutic for intracellular protein replacement in an ultra-rare disease for which there is a considerable unmet need for treatment options. As of the 31 May 2023 data cu...
Given this promising lipid-lowering effect, we tested DC371739 in a Phase I clinical trial (ClinicalTrials.gov, NCT04927221) and found a notable reduction of TC and LDL-C levels in individuals with hypercholesterolemia. In the last decade, several small compound hypolipidemic agents have been ...