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Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:
A Phase 1/2a, Open-Label, Multicenter, Single Arm, Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors

Clinical Trial Summary

This is a Phase 1/2a, open-label, multicenter, dose-escalation/dose-expansion study of YBL-006, in participants with Advanced Solid Tumors. This multicenter study will be conducted in approximately 11-14 participants in the dose escalation phase, and approximately 39-76 participants in dose expansion phase.

Clinical Trial Description

Study will consist of three periods: 1. Screening (up to 28 days) 2. Treatment (28-day, 14-day, or 21-day cycles) 3. Follow-up (up to 3 months) The treatment period will consist of 28-day cycles for the dose escalation phase, and 14-day (Cohorts B1, B2 reserve, and B3) or 21-day (Cohort B2) cycles for the dose expansion phase. Each cycle is comprised of two doses of IP administered as an IV infusion on Days 1 and 15 (dose escalation phase) or one dose of IP administered as an IV infusion on Day 1 (dose expansion phase). The treatment duration will be of 1 year in patients who are responding to the treatment. Dose Escalation: An accelerated titration design will be utilized for the lowest dose cohort (0.5 mg/kg) in the dose escalation part. Whereas the traditional 3 + 3 design will be utilized for the higher dose cohorts until the proposed starting dose for the Expansion Cohort is determined Expansion Cohorts: Up to four tumor-specific expansion cohorts consisting of approximately 39 to 76 participants will evaluate the safety, efficacy, PK, and PD of YBL-006 at the proposed doses of YBL-006" ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04450901
Study type Interventional
Source Y Biologics Inc.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date July 1, 2020
Completion date March 31, 2023
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