A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

June 15, 2025

Primary Completion Date

May 15, 2028

Study Completion Date

September 15, 2028

Conditions
Solid Tumor Malignancy
Interventions
DRUG

SIBP-A18

"SIBP-A18 formulation for injection, Claudin18.2-ADC. Strength: 1.0, 2.0, 3.2, 4.0, 4.8, 5.6, 6.4 and 8.0 mg/kg. Intravenous infusion administration, with a treatment cycle of every 21 days, administered once on the first day of each cycle. The dose escalation stage, 1mg/kg and 2mg/ kg were subjected to accelerated titration, where the safety was evaluated within 21 days after the first administration to one participant. If dose-limiting toxicity (DLT) occurred, the traditional 3+3 dose escalation method was immediately switched. If DLT does not occur, the next dose group will be explored. The third stage will use RP2D for further exploration."

All Listed Sponsors
lead

Shanghai Institute Of Biological Products

INDUSTRY