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RECRUITING
NCT06298058
PHASE1

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

Sponsor: Shanghai Institute Of Biological Products

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Official title: A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2024-05-09

Completion Date

2026-06-30

Last Updated

2026-01-07

Healthy Volunteers

No

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.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China