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.
Subjects must have histologically confirmed locally advanced, recurrent, or metastatic malignancy that has failed to respond to adequate standard treatment(s), or for which no effective standard treatment is available.
Subjects must have documented presence of KRAS p.G12D mutation by a local test identified through tumor tissue or blood collected within the last 5 years.
Subjects must have measurable disease per RECIST v1.1.
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participant has any prior treatment with a specific KRAS G12D inhibitor/degrader or pan RAS inhibitor/degrader.
Subject has uncontrolled intercurrent illness, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, ongoing or active infections, uncontrolled or significant cardiovascular disease, autoimmune or inflammatory disorders or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs), or compromise the ability of the subject to give written consent.
Uncontrolled or untreated brain metastases
Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy
Sequential
D3S-003
DrugOral Tablet
Number of Participants with Dose-Limiting Toxicities (DLTs)
Number of Participants with Adverse Events (AEs)
Maximum tolerated dose (MTD) based on dose limiting toxicities (DLTs)
Phase 2 dose (RP2D)
D3S-003 concentration of drug immediately before the administration of next dose (Ctrough)
D3S-003 maximum observed plasma concentration (Cmax)
D3S-003 time to maximum plasma concentration (tmax)
D3S-003 half-life (t1/2)
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