This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
Have at least one measurable tumor lesion per RECIST v1.1;
ECOG performance status of 0-1;
Life expectancy ≥ 12 weeks;
Patients with active central nervous system metastases or meningeal metastases;
Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;
History of serious cardiovascular and cerebrovascular diseases;
Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;
Single group
SHR-9839
DrugWeekly fixed dose injection of SHR-9839
Maximum tolerated dose (MTD) or maximum administered dose (MAD)
Incidence and category of dose limiting toxicities (DLTs) during the first 4 week cycle of SHR-9839 treatment
Recommended Phase 2 dose (RP2D)
RP2D will be determined on the basis of evaluation on MTD/MAD, PK, PD, efficacy data in dose escalation and dose expansion stages.
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)
Assess safety and tolerability of SHR-9839 by way of adverse events (CTCAE v5.0).
PK parameter: Tmax of SHR-9839
Time to maximum concentration of SHR-9839
PK parameter: Cmax of SHR-9839
Maximum concentration of SHR-9839
PK parameter: AUC0-t of SHR-9839
Area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-9839
PK parameter: AUC0-∞ of SHR-9839
Area under the concentration-time curve from time 0 to infinity of SHR-9839
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