A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.

PHASE1RecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

May 9, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

June 30, 2026

Conditions
Advanced Solid Tumor
Interventions
DRUG

SIBP-A13 formulation for injection

"SIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion). Starting from the lowest dose, when the former does not meet the termination criteria, then start the next dose group study until Maximum Tolerated Dose (MTD). The study adopts a 3+3 dose increasing design. Administration period: divided into single administration and multiple administration. Single dose administration: The participants are administered a single dose on the first day for a total of 21 days of observation, and complete the examinations and evaluations specify in the protocol. If dose-limiting toxicity (DLT) does not occur, the participant enters a multiple dosing period. Multiple administration: administration every 3 weeks."

Trial Locations (1)

Unknown

RECRUITING

Shanghai Pulmonary Hospital, Shanghai

All Listed Sponsors
collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

lead

Shanghai Institute Of Biological Products

INDUSTRY