This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
D3 Bio Investigative Site
Detroit, Michigan, United States
D3 Bio Investigative Site
New York, New York, United States
D3 Bio Investigative Site
Blacktown, New South Wales, Australia
Number of Participants With Adverse Events (AEs)
Time frame: First dose until 30 days after the last dose (or specified in the protocol)
Maximum tolerated dose (MTD) based on Dose limiting toxicities (DLTs)
Time frame: First dose up to 24 months
Recommended Phase 2 dose (RP2D)
Time frame: First dose up to 24 months
Part 1: D3S-002 maximum observed plasma concentration (Cmax)
Time frame: First dose up to 24 months
Part 2: D3S-002 and D3S-001 maximum observed plasma concentration (Cmax)
Time frame: First dose up to 24 months
Part 1: D3S-002 time to maximum plasma concentration (tmax)
Time frame: First dose up to 24 months
Part 2: D3S-002 and D3S-001 time to maximum plasma concentration (tmax)
Time frame: First dose up to 24 months
Part 1: D3S-002 half-life (t1/2)
Time frame: First dose up to 24 months
Part 2: D3S-002 and D3S-001 half-life (t1/2)
Time frame: First dose up to 24 months
Part 1: D3S-002 area under the concentration-time curve (AUC)
Time frame: First dose up to 24 months
Part 2: D3S-002 and D3S-001 area under the concentration-time curve (AUC)
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D3 Bio Investigative Site
Bedford Park, South Australia, Australia
D3 Bio Investigative Site
Nedlands, Western Australia, Australia
D3 Bio Investigative Site
Beijing, Beijing Municipality, China
D3 Bio Investigative Site
Guangzhou, Guangdong, China
D3 Bio Investigative Site
Harbin, Heilong Jiang, China
D3 Bio Investigative Site
Shanghai, Shanghai Municipality, China
D3 Bio Investigative Site
Hangzhou, Zhejiang, China
Time frame: First dose up to 24 months
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Until disease progression or end of treatment (up to approximately 24 months)
Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Until disease progression or end of treatment (up to approximately 24 months)
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Until disease progression or end of treatment (up to approximately 24 months)