Procedures
asthenia, nausea, DLTs, neutropenia, diarrhea, toxicity, toxicities, thrombocytopenia, uveitis, vomiting, C fever, PD, non-hematologic adverse reactions
NEUTROPENIA, DISEASE, THROMBOCYTOPENIA, UVEITIS, CARDIAC INSUFFICIENCY, BLEEDING TENDENCY, INTERSTITIAL PNEUMONITIS
In the dose-escalation part, patients received QL1604 via intravenous infusion at a dose level assigned according to the sequence of enrollment. Each treatment cycle lasted for 28 days. Treatment was continued until progression of the disease (PD), unacceptable toxicity, confirmed complete response (CR), loss to follow-up, or patient or investigator decision, whichever occurred first. Dose-limiting toxicities (DLTs) were observed during the 28-day period after the first dose of study drug at each dose level and included: grade ≥2 uveitis; grade ≥2 interstitial pneumonitis (grade 2 interstitial pneumonitis lasting for >7 days after glucocorticoid treatment); grade ≥3 non-hematologic adverse reactions (except for transient electrolyte abnormalities, diarrhea, nausea, and vomiting recovered to ≤grade 2 within 3 days after best support care, and asthenia recovered to ≤grade 2 within 7 days after best support care); grade ≥2 cardiac insufficiency; grade 4 thrombocytopenia or grade 3 thrombocytopenia with obvious bleeding tendency; grade 4 neutropenia lasting for ≥3 days or grade 3 neutropenia with ≥38.3°C fever; and other grade 4 hematologic toxicities. Decisions on dose escalation in this phase were made on the basis of the incidence of DLTs seen during the DLT observation period. The expansion phase for 3 mg/kg Q2W and 3 mg/kg Q3W cohorts started after the DLT observation period was finished for the last patient in 3 mg/kg cohort in dose-escalation phase. The expansion phase for 200 mg of fixed dose Q3W started after the DLT observation period was finished for the last patient in 10 mg/kg cohort in dose-escalation phase.