Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
Anus | Breast - Female | Breast - Male | Colon | Corpus Uteri | Esophagus | Hodgkin's Lymphoma | Kidney | Larynx | Lip, Oral Cavity and Pharynx | Liver | Lung | Melanoma, skin | Other Digestive Organ | Other Endocrine System | Other Female Genital | Other Male Genital | Other Respiratory and Intrathoracic Organs | Other Skin | Other Urinary | Ovary | Pancreas | Prostate | Rectum | Small Intestine | Soft Tissue | Stomach | Thyroid | Phase I | Unknown Sites | Breast | Cervix | Urinary Bladder
What is the purpose of this trial?
This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.
The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.
- Trial withFLX, Bio, Inc.
- Start Date01/03/2019
- End Date04/30/2021
- Last Updated08/13/2020
- Study HIC#2000023915