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

NCT06298058 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-01-07

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    collaborator OTHER

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Caicun Zhou, Doctor · Shanghai Pulmonary Hospital, Shanghai, China

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
2024-05-09
Primary Completion
2026-04-30
Completion
2026-06-30

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 NCT06298058 on ClinicalTrials.gov