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Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors — BC3195  

Locally Advanced or Metastatic Solid Tumors Clinical Trial

Official title:
A Phase Ia/Ib, Open-Label, First-in-human, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Summary

This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.

Clinical Trial Description

This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors. The patients in whom standard treatment has failed (either due to disease progression or intolerance), who meet the criteria will receive BC3195 via intravenous (IV) in 21-day treatment cycles. A Safety Monitoring Committee (SMC) will be established to decide the dose levels to be administered and dose regimen during dose escalation based on a thorough review of all the safety, PK (if applicable), and other relevant data from the previous dose cohort, and to determine the MTD and the putative RP2D for dose expansion. ;

Study Design

Related Conditions & MeSH terms

  • Locally Advanced or Metastatic Solid Tumors
  • Neoplasms
Clinical Trial Details
NCT number NCT05957471
Study type Interventional
Source Biocity Biopharmaceutics Co., Ltd.
Contact Yilong Wu
Phone 021-38804518
Email syylwu@live.cn
Status Recruiting
Phase Phase 1
Start date June 26, 2023
Completion date June 2025
View Details
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