This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Oral Tablet
D3 Bio Investigative Site 1404
New Haven, Connecticut, United States
RECRUITINGD3 Bio Investigative Site 1403
Houston, Texas, United States
RECRUITINGD3 Bio Investigative Site 1402
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
Number of Participants with Adverse Events (AEs)
Time frame: From screening visit 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 7 months
Phase 2 dose (RP2D)
Time frame: First dose up to 7 months
D3S-003 concentration of drug immediately before the administration of next dose (Ctrough)
Time frame: First dose up to 7 months
D3S-003 maximum observed plasma concentration (Cmax)
Time frame: First dose up to 7 months
D3S-003 time to maximum plasma concentration (tmax)
Time frame: First dose up to 7 months
D3S-003 half-life (t1/2)
Time frame: First dose up to 7 months
D3S-003 area under the concentration-time curve (AUC)
Time frame: First dose up to 7 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 7 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
San Antonio, Texas, United States
D3 Bio Investigative Site 1101
Macquarie Park, New South Wales, Australia
RECRUITINGD3 Bio Investigative Site 1103
Randwick, New South Wales, Australia
RECRUITINGD3 Bio Investigative Site 1102
Malvern, Victoria, Australia
RECRUITINGD3 Bio Investigative Site 1201
Seoul, South Korea
RECRUITINGD3 Bio Investigative Site 1203
Seoul, South Korea
RECRUITINGD3 Bio Investigative Site 1202
Seoul, South Korea
RECRUITINGDuration of Response (DOR) 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 7 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 7 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 7 months)