RecruitingPhase 1NCT05194982

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

570 participants

Start Date

Nov 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be evaluated.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called BL-B01D1 in people with advanced or metastatic solid tumors that haven't responded to standard treatments. Researchers want to find the right dose and see how well it works. **You may be eligible if...** - You are 18 or older (up to 75 for early phase) - You have a confirmed advanced or metastatic solid tumor with no remaining standard treatment options - You have measurable cancer that can be tracked on scans - Your heart, kidneys, liver, and blood counts are within acceptable ranges - Your expected survival is at least 3 months - You are in generally good physical condition (able to care for yourself) **You may NOT be eligible if...** - You have had major cancer treatments within the past 4 weeks - You have a serious heart condition (heart failure, recent heart attack, irregular heartbeat) - You have active autoimmune diseases requiring ongoing treatment (e.g., lupus, rheumatoid arthritis) - You have another active cancer diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion.


Locations(8)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

View Full Details on ClinicalTrials.gov

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NCT05194982


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