A Phase I, Open-Label, Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation
Details
This first-in-human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of D3S-001 and identify the recommended Phase 2 dose (RP2D) when D3S-001 is administered as monotherapy to subjects with advanced solid tumors with the Kirsten rat sarcoma viral oncogene homolog gene (KRAS) p.G12C mutation.
Eligibility
You can join if...
Please note this may not be a complete list of eligibility criteria. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined; your study team will go through the study eligibility criteria with you to verify if you qualify for participation in this study.
Inclusion Requirements
You can participate in this study if
Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
Subject must have measurable disease per RECIST v1.1.
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subject must have adequate organ and marrow function within the screening period.
Exclusion Requirements
You cannot participate in this study if
Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, 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 informed consent.
Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade >2 (with exception of vitiligo or alopecia).
Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).