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A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients. - Trial NCT06298058

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.

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NCT06298058
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06298058
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A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.
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.

Study Focus

Advanced Solid Tumor

SIBP-A13 formulation for injection

Interventional

drug

Sponsor & Location

Shanghai Institute Of Biological Products

Timeline & Enrollment

Phase 1

Mar 12, 2024

Jun 30, 2026

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 ยฝ (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, unspecified
Malignant neoplasm: Prepuce
Malignant neoplasm: Connective and soft tissue, unspecified
Malignant neoplasm: Parametrium
Malignant neoplasm of other connective and soft tissue

Data Source

ClinicalTrials.gov

NCT06298058

Non-Device Trial