Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SY… (NCT07122063) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors
China266 participantsStarted 2025-08-11
Plain-language summary
This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study. It aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of SYS6045 in patients with HER2-positive, expressing, or mutated advanced solid tumors.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age : ≥18 years.
✓. ECOG Performance Status : 0-1.
✓. Tumor Lesion Requirements:
✓. Life Expectancy: ≥3 months.
✓. Adequate Organ Function (confirmed by laboratory tests within 14 days prior to enrollment, without transfusion or hematopoietic growth factor support):
✓. Left Ventricular Ejection Fraction (LVEF): ≥50% during screening.
✓. Fertile males or females must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the trial and for ≥7 months after the last dose. Women of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment.
✓. Capable of understanding and voluntarily signing the informed consent form Additional Inclusion Criteria for Phase I (Dose Escalation Phase)
Exclusion criteria
✕. Prior treatment with HER2-targeted ADC carrying a topoisomerase I inhibitor payload (e.g., DS-8201) or other TOP1 ADCs (Patients who received such agents in the neoadjuvant/adjuvant setting and experienced recurrence ≥12 months after treatment completion may be enrolled)\[Applicable to: Phase I PK expansion and Phase II dose expansion studies\].
✕. Active neurological conditions, including: Spinal cord compression, clinically active brain metastases (untreated, symptomatic, or requiring corticosteroids/anticonvulsants for symptom control), carcinomatous meningitis or leptomeningeal disease. Asymptomatic CNS metastases with stable status ≥4 weeks after therapy and on tapering corticosteroids (≤10 mg/day prednisone equivalent) are allowed.
✕. Unresolved toxicities from prior anticancer therapy Not recovered to CTCAE v5.0 Grade ≤1 or baseline levels(Alopecia, hyperpigmentation, or isolated lab abnormalities deemed non-risky by the investigator).
✕. Recent anticancer treatments (relative to first dose): Immunotherapy/macromolecular agents ≤4 weeks, Cytotoxic chemotherapy/small-molecule therapy ≤2 weeks, Traditional Chinese medicine ≤2 weeks.
✕. Strong CYP3A4 inducers/inhibitors or OATP1B1/1B3 inhibitors≤2 weeks before first dose, or Within 5 half-lives (whichever is longer).
✕. Major surgery or invasive procedures≤28 days before first dose Planned tumor resection during the study period.
✕. Known severe allergies to any component of the investigational drug, History of severe hypersensitivity to monoclonal antibodies (e.g., trastuzumab) .