A Phase I Study to Assess the Safety and Tolerability of BL0006 for Patients With Advanced Solid Tumours

NCT06247657 | Recruiting Phase 1

• 1 other identifier: BL0006-101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

This is the first in human study of BL0006, and the primary objective is to evaluate the safety and tolerability of BL0006 as a single agent in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose(MTD)

  Based on the incidence of Dose-Limiting Toxicity (DLT) of BL0006 in patients with advanced solid tumors, MTD is determined.

  Throughout the study for approximately 2 years

• Recommended Phase II Dose(RP2D)

  RP2D will be evaluated according to all the available safety, PK and efficacy data.

  Throughout the study for approximately 2 years

Secondary Outcomes (7)

• Area under the plasma concentration-time curve (AUC)

  Cycle 1 day 1 to Cycle 2 day 2（each cycle is 21 days）

• Half life (t1/2)

  Cycle 1 day 1 to Cycle 2 day 2（each cycle is 21 days）

• Disease Control Rate(DCR)

  Throughout the study for approximately 2 years

• Objective response rate(ORR)

  Throughout the study for approximately 2 years

• Progression-Free Survival (PFS)

  Throughout the study for approximately 2 years

Study Arms (1)

BL0006

EXPERIMENTAL

Patients will be administered BL0006 via intravenous infusion at the corresponding dose level on days 1 and 8 of a 21-days treatment cycle.

Drug: BL0006

Interventions

BL0006 DRUG

Patients will be administered BL0006 via intravenous infusion at the corresponding dose level on days 1 and 8 of a 21-days treatment cycle.

BL0006

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consent form.
• Aged ≥ 18 years, male and female.
• The dose-escalation stage: patients with histologically or cytologically confirmed, unresectable or metastatic advanced solid tumors that have failed despite standard therapy, for whom no standard therapy exists, or who have refused standard therapy.
• The dose-expansion stage: patients with histologically or cytologically confirmed, unresectable or metastatic hepatocellular carcinoma (HCC) who are not suitable for surgery and local treatment, and who have failed despite standard therapy, or who have refused standard therapy. And other potential tumors (selection based on the results of BL0006-101 Study dose-escalation stage) that have failed despite standard therapy, for whom no standard therapy exists, or who have refused standard therapy.
• Patients with at least one measurable lesion per RECIST (v1.1) (applicable to the dose-expansion stage only).
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.
• Life expectancy period ≥ 12 weeks.
• A male patient must agree to use adequate contraception from screening through at least 6 months after the last dose of investigational product BL0006.
• Women of childbearing potential must have a negative pregnancy test prior to the dosing administration, and agree to use adequate contraception from screening through at least 6 months after the last dose of investigational product BL0006. A female participant of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhoea, follicle stimulating hormone (FSH) level \> 40 mIU/mL at screening, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms); or have had surgical bilateral oophorectomy, hysterectomy or bilateral tubal ligation beyond 6 weeks prior to screening.

You may not qualify if:

• Patients with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis.
• Patients who have a history of another primary malignancy (with the exception of subjects with cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix). A patient who has had no evidence of disease from another primary cancer for 5 or more years is allowed to participate in the study.
• Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.
• Patients with a history of allogeneic transplantation of organs, bone marrow or stem cell. Patients with a history of hepatic encephalopathy.
• Patients with Gilbert's syndrome disease.
• Patients with homozygous for UGT1A1\*28 or UGT1A1\*6.
• Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
• New York Heart Association class III-IV for cardiac insufficiency or left ventricular ejection fraction \< 50%.
• Patients with poorly controlled arrhythmia: QTc interval \> 480 ms calculated by Fridericia's formula, or congenital syndrome of prolonged QT interval.
• Any of the following within 6 months prior to the screening: myocardial infarction, severe or unstable angina, congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism or other clinically significant thromboembolic disease, or coronary artery bypass graft.
• Clinically significant resting bradycardia. Patients with other clinically significant cardiovascular disease who were assessed as unsuitable for this study by the investigator.
• Patients with active chronic inflammatory bowel disease at screening (such as Ulcerative Colitis, Crohn's disease), ≥ grade 2 anorexia, nausea, vomiting or signs of intestinal obstruction. Or patients with a history of intestinal obstruction, gastrointestinal perforation, or clinically significant gastrointestinal bleeding within the 6 months prior to screening.
• Known history of clinically significant active Chronic Obstructive Pulmonary Disease (COPD), or other moderate-to-severe chronic respiratory illness present within 6 months.
• Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection.
• Patients with active hepatitis C or chronic hepatitis B at screening ("active hepatitis" defined as HCV RNA level ≥ 200 IU/mL for hepatitis C or HBV DNA level ≥ 2000 IU/mL for hepatitis B at screening). In addition, eligible hepatitis B or hepatitis C patients must agree to antiviral treatment according to the treatment guidelines.

Sponsors & Collaborators

• Shanghai Best-Link Bioscience, LLC: lead

Study Sites (2)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

NOT YET RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Weixing Mao

CONTACT

+86-021-58383963; maoweixing@bestlinkbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 8, 2024
• Study Start: January 3, 2024
• Primary Completion: October 1, 2024
• Study Completion: May 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

CN (2)