A Study of SY-5933 in Patients With Advanced Solid Tumors Harboring the KRAS p.G12C Mutation (NCT06006793) | Clinical Trial Compass
UnknownPhase 1
A Study of SY-5933 in Patients With Advanced Solid Tumors Harboring the KRAS p.G12C Mutation
China50 participantsStarted 2023-08-10
Plain-language summary
This is a single-arm, open-label, phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of SY-5933 in patients with KRAS p.G12C mutant advanced solid tumors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Men or women ≥ 18 years old
✓. Eastern Collaboration Oncology Group (ECOG) performance status (PS) scored of 0-1.
✓. Estimated life expectancy \>12 weeks.
✓. Patients must have at least one assessable lesion in the dose-escalation part and one measurable lesion in the dose-expansion part per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
✓. In the dose-escalation part, patients must have histologically or cytologically confirmed advanced solid tumors harboring the KRAS p.G12C mutation and have progressed after standard therapy, or standard therapy is inappropriate or unavailable.
✓. Adequate organ function as defined in the below:
✓. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the first dose. Both male and female patients of reproductive potential must be willing to abstain completely or agree to use an appropriate method of contraception during the entire study duration and for at least 3 months after the last dose of study medication.
✓. Willingness and ability to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
Exclusion criteria
✕. Dose-escalation phase: patients with known driver alterations other than KRAS p.G12C, e.g., EGFR, ALK, ROS1, RET, TRK, etc. (Enrollment of patients with co-mutations may be discussed with the investigator).
✕. Dose-expansion phase: prior use of selective KRAS inhibitors.
What they're measuring
1
Incidence of Dose-limiting toxicities (DLTs)
Timeframe: 31 days after the first dose (single dose for 3 days and dose-escalation cycle 1 for 28 days)
✕. Patients who received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, and other anti-tumor treatment within 3 weeks before the first administration, except for the following: Nitrosourea or mitomycin C was received within 6 weeks before the first administration; Oral fluoropyrimidines and small molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first administration; Chinese proprietary medicines with anti-tumor indications were received within 2 weeks before the first administration.
✕. Received other unapproved investigational drugs or treatments within 4 weeks prior to the first administration.
✕. Have undergone major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks prior to the first administration.
✕. Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade ≤ 1(exceptions for toxicities judged by the investigator to be of no safety concern, e.g. alopecia, grade 2 peripheral neurotoxicity, etc.).
✕. Presence of spinal cord compression, meningeal metastases, clinically symptomatic brain metastases, or need for increased steroid doses to control central nervous system (CNS) disease; patients with symptomatic CNS metastases that are already under control may be eligible for this study.
✕. Patients with active infection who need systematic anti-infective therapy within 2 weeks prior to the first administration.