Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer (FLX475-02)
Johns Hopkins Kimmel Cancer Center in Baltimore
This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety (MTD and/or RP2D) and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.
All subjects must have histologically or cytologically confirmed, advanced or metastatic tumors and (1) have disease progression after treatment with other available therapies for metastatic disease that are known to confer clinical benefit or (2) do not tolerate or refuse standard treatment(s); Subject must have one of the following diagnoses to be eligible for enrollment into a doseescalation cohort (Parts 1a and 1b), or otherwise have pre-approval from the Sponsor medical monitor for any diagnoses not listed below:a. Stage IIIB/IV squamous or non-squamous non-small cell lung carcinoma (NSCLC)b. Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC;specifically of the oral cavity, oropharynx, hypopharynx, or larynx; andnasopharyngeal carcinoma)c. Metastatic hormone receptor positive, HER2-positive, or triple-negative breast cancerd. Locally advanced or metastatic urothelial carcinoma (UC)e. Locally advanced, recurrent, or metastatic gastric cancer (GC)f. Locally advanced, recurrent, or metastatic colorectal adenocarcinoma (CRC)g. Locally advanced, recurrent, or metastatic esophageal or esophagogastric junction cancerh. Recurrent or metastatic cervical squamous cell carcinoma or endocervicaladenocarcinomai. Advanced recurrent platinum-resistant ovarian cancerj. Metastatic melanomak. Recurrent classical Hodgkin lymphoma; ECOG performance status (PS) score of 0 or 1; Subjects enrolled must be willing and able to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated; Ability to swallow tablets without difficulty
Treatment Phase comprising up to 35 treatment cycles for FLX475 and a maximum of2 years’ treatment (35 doses) for pembrolizumab and FLX475, unless another intervening reason for discontinuation occurs. Each treatment cycle is 3 weeks in duration.
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