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A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients.

NCT06512116 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-01-07

No results posted yet for this study

Summary

To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A17 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

SIBP-A17

Strength: 1, 2, 4, 5, 6 or 8 mg. 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 subject. 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, and the dose exploration starting from 4mg/kg will adopt a "3+3" dose escalation design.

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Jing Huang, Doctor · Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical

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
2024-07-23
Primary Completion
2026-07-30
Completion
2026-12-30

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 NCT06512116 on ClinicalTrials.gov