A Phase 1b Dose Escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX51107 in Subjects with Advanced Malignancies

Protocol: 
AAAQ9209
Phase: 
I

A Phase 1b Dose Escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX51107 in Subjects with Advanced Malignancies

There will be up to 60 subjects enrolled into the study nationwide, divided into two different treatment groups. The treatment groups are as follows: Treatment Group A: Subjects with an advanced solid tumor (including lymphoma) Treatment Group B: Subjects with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) There will be several dose levels of PLX51107 that will be explored to determine the best dose. At the beginning of the study, 3 Subjects in each treatment group will be treated with a low dose of PLX51107. If this dose does not cause bad side effects, the drug will be given at a higher dose for the next 3 new Subjects in each treatment group who take part in the study. Dose increases will continue until the highest, most tolerable dose is determined for PLX51107 in each treatment group.

Are you Eligible? (Inclusion Criteria)

Confirmed diagnosis of an advanced malignancy in one of two treatment
groups:
a. Treatment Group A: any advanced solid tumor (including lymphomas)
b. Treatment Group B: relapsed or refractory AML or high-risk MDS, defined
as IPSS INT-2 or greater disease (Maes 1999)
2. Progressed following at least 1 line of prior anti-cancer therapy for the
advanced disease and
there is no further standard therapeutic option available (including
subjects who are intolerant to the approved/available therapies)
3. Age >= 18 years
4. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-2

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States