This is an open-label, dose escalation and dose expansion study of MDK-703 as a monotherapy and in combination with other cancer therapies in adult study participants with advanced or metastatic solid tumors.
This is a Phase 1/2, open-label, multicenter, dose escalation and dose expansion study evaluating MDK-703 in adult study participants with advanced or metastatic solid tumors. This study will initially commence with dose escalation to evaluate the safety/tolerability of MDK-703 as a monotherapy and in combination with other cancer therapies. Once the monotherapy and/or combination therapy maximum tolerated dose (MTD), optimal biological dose (OBD), and/or recommended dose (RD) has been determined, then dose expansion of MDK-703 may commence in select populations of interest. The study will also evaluate the anti-tumor activity and pharmacokinetic (PK) and pharmacodynamic (PD) profiles of MDK-703 as a monotherapy and in combination with other cancer therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
MDK-703 will be administered as specified under Arm description.
Checkpoint inhibitor will be administered as specified under Arm description.
Sarah Cannon Research Institute (Florida Cancer Specialists)
Sarasota, Florida, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
NEXT Oncology Austin
Austin, Texas, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Dose Limiting Toxicities (DLT)
Based on toxicities observed from time of first dose through first cycle of treatment
Time frame: Assessed up to 24 months
Maximum tolerated dose (MTD)
Based on toxicities observed
Time frame: Assessed up to 24 months
Optimal biological dose (OBD)
Based on toxicities observed
Time frame: Assessed up to 24 months
Recommended dose (RD)
Based on toxicities observed
Time frame: Assessed up to 24 months
Adverse events (AE)
Incidence and severity of treatment-emergent AEs and serious AEs as assessed by CTCAE v5.0
Time frame: Assessed up to 24 months
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months
Time to Response (TTR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months
Disease Control Rate (DCR)
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The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months
Progression-Free Survival (PFS)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months
Overall Survival (OS)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months
Blood concentration of MDK-703
Blood concentration of MDK-703 at various timepoints
Time frame: Assessed up to 24 months
Time to achieve maximum blood concentration
Time to achieve maximum blood concentration of MDK-703
Time frame: Assessed up to 24 months