This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
442
Number of Participants With Adverse Events (AEs)
Time frame: From first dose until 30 days after the last dose (or specified in the protocol).
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
D3S-001 maximum observed plasma concentration (Cmax)
Time frame: Up to 24 months.
D3S-001 time to maximum plasma concentration (tmax)
Time frame: Up to 24 months.
D3S-001 half-life (t1/2)
Time frame: Up to 24 months.
D3S-001 area under the concentration-time curve (AUC)
Time frame: 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: Up to 24 months.
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Up to 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: Up to 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intravenous
Intravenous
Intravenous
D3 Bio Investigative Site 0402
Orange, California, United States
RECRUITINGD3 Bio Investigative Site 0407
Palo Alto, California, United States
RECRUITINGD3 Bio Investigative Site 0404
Denver, Colorado, United States
RECRUITINGD3 Bio Investigative Site 0406
Sarasota, Florida, United States
RECRUITINGD3 Bio Investigative Site 0401
Detroit, Michigan, United States
RECRUITINGD3 Bio Investigative Site 0405
Nashville, Tennessee, United States
RECRUITINGD3 Bio Investigative Site 0403
Houston, Texas, United States
RECRUITINGD3 Bio Investigative Site 0102
Sydney, New South Wales, Australia
RECRUITINGD3 Bio Investigative Site 0101
Malvern, Victoria, Australia
RECRUITINGD3 Bio Investigative Site 0105
Melbourne, Victoria, Australia
RECRUITING...and 41 more locations
Time frame: Up to 24 months.