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

NCT07205198 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-08

No results posted yet for this study

Summary

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

Conditions

  • Advanced Tumors

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.

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Li Zhang, Docter · Shanghai Institute Of Biological Products

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2028-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07205198 on ClinicalTrials.gov