About this trial
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-4298 injection in patients with malignant solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
ECOG performance score of 0-1.
Life expectancy ≥ 3 months.
Have at least one measurable tumor lesion per RECIST v1.1.
Disqualifiers
Subjects with active central nervous system metastases or meningeal metastases.
Suffering from other malignant tumors within five years before the first use of the drug.
History of serious cardiovascular and cerebrovascular diseases.
Clinically significant bleeding symptoms occurred within 3 months before the first dose of study drug.
Trial design
Single group
Treatments tested in this trial
SHR-4298 Injection
DrugSHR-4298 injection.
Treatment groups
Trial outcomes
Primary outcomes
Incidence and severity of adverse events (AEs).
Incidence and severity of serious adverse events (SAEs).
Maximum Tolerated Dose (MTD).
Maximum Applicable Dose (MAD).
Secondary outcomes
Overall response rate (ORR).
Duration of response (DoR).
Disease control rate (DCR).
Progression-free survival (PFS).
Sponsors and contacts
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