An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.
Categories (click each to see list of all clinical trials associated with that category): Myeloma/Plasma Cell Dyscrasia (ONC)
Current Status: Open
Phase: I/II (Cancer Control)
Principal Investigator: Holstein, Sarah
Contact Information:
Marnee Strege
+1 402-559-8155
marnee.strege@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04068597?term=NCT04068597&rank=1#participation-criteria
Summary
Primary objective
To assess the safety and explore the recommended Phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of CCS1477 when given as monotherapy and in combination in patients with haematological malignancies (NHL, MM, AML and higher-risk MDS).
Secondary objectives
To characterize the pharmacokinetics (PK) of CCS1477, following a single dose and at steady state after multiple dosing, when given as monotherapy or in combination.
To characterize the PK of venetoclax when dosed in combination with CCS1477.
To assess preliminary tumor response/activity of CCS1477 as monotherapy and in combination in patients with haematological malignancies (NHL, MM, AML and Higher-risk MDS).
To characterize the PK of CCS1477 when dosed in combination with posaconazole.
Exploratory objectives
To explore the relationship between PK, safety, efficacy and blood borne and tissue biomarkers, if appropriate.
To collect and store blood and tumor samples for exploratory biomarker analysis which may include, but will not be limited to, understanding mechanisms of response to treatment (where response is defined broadly to include efficacy, tolerability or safety) or disease progression. This may include the analysis of tumor-specific and circulating biomarkers, such as tumor DNA, mRNA, proteins or metabolites.