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Phase I Study of BL0020, a Novel Anti-tumor Drug, in Adult Subjects With Advanced Solid Tumors

NCT05886868 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-11-29

No results posted yet for this study

Summary

This is the first in human study of BL0020, and the primary objective is to evaluate the safety and tolerability, and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of BL0020 as a single agent in patients with advanced solid tumors.

This study consists of two parts: Part A (dose escalation stage) and Part B (dose expansion stage).

The study includes screening, treatment and follow-up periods.

In part A, "3+ 3" will be used for dose escalation.

In part B, the dose level and/or enrolled patient population for dose-expansion may be adjusted based on available data on the safety, PK and preliminary efficacy gained from the patients.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

BL0020

Dose Escalation Stage: BL0020 will be administered via intravenous infusion on days 1 of a 21-days treatment cycle. Dose Expansion Stage: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation Stage.

Sponsors & Collaborators

  • Shanghai Best-Link Bioscience, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2024-07-31
Completion
2025-02-28
FDA Drug
Yes

Countries

  • Australia
  • 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 NCT05886868 on ClinicalTrials.gov