Phase I/II Study of SY-5007, a RET Inhibitor, in Patients With RET-altered Advanced Solid Tumor (NCT05278364) | Clinical Trial Compass
UnknownPhase 1/2
Phase I/II Study of SY-5007, a RET Inhibitor, in Patients With RET-altered Advanced Solid Tumor
China184 participantsStarted 2021-04-23
Plain-language summary
This is a phase I/II, open-label, multi-center, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of SY-5007 administered orally to participants with advanced solid tumors, including RET Fusion-Positive NSCLC or RET-mutated MTC or other RET-altered advanced solid tumor.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, at least 18 years of age.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
✓. Estimated life expectancy \>12 weeks.
✓. Patients must have at least one assessable lesion in dose-escalation part and one measurable lesion in dose-expansion part per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
✓. Dose-escalation Part: patients must have histological or cytological confirmed advanced solid tumours with RET alteration (fusion or mutation) and have progressed after standard therapy, or no standard or available curative therapy exists.
✓. Patients must have 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, male and female patients of childbearing potential must be willing to completely abstain 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-expansion Part: Patient's cancer has a known primary driver alteration other than RET. e.g. EGFR, ALK, ROS1, KRAS, etc.
✕. Dose-expansion Part: Patients previously treated with a selective RET inhibitor.
What they're measuring
1
Phase I: Determine the dose-limiting toxicities (DLT) during the first 28-day cycle of SY-5007 treatment
Timeframe: Dose-escalation Cycle 1 (each cycle is 28 days)
2
Phase I: Number of patients with adverse events and serious adverse events
Timeframe: Up to 24 months
3
Phase II: Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
✕. Patients received systemic antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, endocrine therapy, or immunotherapy within 3 weeks prior to the first dose, except for the following:
✕. Patients received other unlisted clinical trial drugs or treatments within 4 weeks prior to the first dose.
✕. Patients underwent major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks prior to the first dose.
✕. Adverse effects of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade rating of ≤ grade 1 (except for toxicity judged by the investigator be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.)
✕. Patients have symptomatic central nervous system (CNS) metastases, meningeal metastases, or a primary CNS tumor that is associated with progressive neurological symptoms.
✕. Patients with active uncontrolled systemic bacterial, viral, or fungal infection despite optimal treatment (chronic disease screening not required).