NCT06298058

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

Name: Clinical Trial NCT06298058
Creator: Shanghai Institute Of Biological Products
Keywords: Advanced Solid Tumor, SIBP-A13 formulation for injection, Phase 1, drug, clinical trial

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.

Shanghai Institute Of Biological Products·Phase 1·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Advanced Solid Tumor
Drug/Device/Intervention: SIBP-A13 formulation for injection
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Shanghai Institute Of Biological Products

Timeline & enrollment

Phase: Phase 1
Start date: Mar 12, 2024
End date: Jun 30, 2026
Enrollment: 144 participants

Primary outcome

AE (Adverse Events),SAE (Serious Adverse Events),AUC (Area Under The Plasma Concentration Versus Time Curve),Cmax (Peak Plasma Concentration),Tmax (Peak Time),T ½ (Terminal elimination half-life),CL (Clearance Rate)

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).

ICD-10 classifications

Carcinoma in situ, unspecifiedMalignant neoplasm: PrepuceMalignant neoplasm: Connective and soft tissue, unspecifiedMalignant neoplasm: ParametriumMalignant neoplasm of other connective and soft tissue

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06298058
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06298058 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shanghai Institute Of Biological Products and is currently Not yet recruiting. The study focuses on Advanced Solid Tumor. Target enrollment is 144 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.