Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07205198
PHASE1

A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects.

Sponsor: Shanghai Institute Of Biological Products

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Official title: A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-10-31

Completion Date

2028-12-30

Last Updated

2026-01-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

SIBP-A10

SIBP-A10 injection. Strength: 0.5, 1.5, 3, 5, 7, 10 and 15 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,0.5 mg/kg group was subjected to accelerated titration, where the safety was evaluated within 21 days after the first administration to one subject. If unacceptable toxic reactions occurred, the traditional "3+3" dose escalation method was immediately switched. If unacceptable toxic reactions do not occur, the next dose group will be explored. The third stage will use RP2D for further exploration.

Locations (1)

Zhongshan Hospital Affiliated to Dalian University

Dalian, Liaoning, China