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Advanced Solid TumorPhase 1NCT06247657

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

A Phase 1 study testing BL0006 in people with Advanced Solid Tumor, run by Shanghai Best-Link Bioscience, LLC at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
BL0006
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
2 sitesChina
Study dates
3 Jan 2024to May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Active infections requiring antibiotic intravenous therapy within 4 weeks prior to screening.
  • Patients with any other medical conditions that, in the opinion of the Investigator, could affect the patient's participation in the study such as:
  • Disease management may be jeopardized by treatment with this study treatment. Uncontrolled diabetes mellitus, HbA1c ≥ 8%. Moderate or severe hepatic impairment, i.e., Child-Pugh class B or C.
  • Those who received blood transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to screening.
  • Patients who have not sufficient baseline organ function and whose laboratory data meet the following criteria at enrollment:
  • Absolute Neutrophil Count (ANC) < 1.5×109/L. Serum albumin < 30 g/L. Total bilirubin > 1.5×ULN. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3×ULN without liver metastases or primary liver cancer. AST or ALT > 5×ULN if the patient has documented primary liver cancer or liver metastases.
  • Hemoglobin < 90 g/L. Platelets < 100×109 /L. Creatinine clearance < 50 mL/min.
  • Those who are known to be allergic to the active ingredient or excipients of the investigational product BL0006, or who have a predisposition to allergy.
  • Patients with a history of an anaphylactic reaction to irinotecan, irinotecan liposome, sacituzumab govitecan-hziy or other topoisomerase I inhibitors, or ≥ Grade 3 hematology or gastrointestinal toxicity prior to irinotecan, irinotecan liposome, sacituzumab govitecan-hziy or other topoisomerase I inhibitors.
  • Use of UGT1A1 inhibitors or inducers within 5 half-lives at the time of investigational product BL0006 administration, or planned use of UGT1A1 inhibitors or inducers within 2 weeks prior to administration of BL0006 (whichever is shorter), or are expected to continue such therapy during the study.
  • Anti-tumor therapy within 5 half-lives at the time of investigational product BL0006 administration, or anti-tumor therapy within 4 weeks prior to administration of BL0006 (whichever is shorter), therapy including chemotherapy, biologic therapy, immunotherapy, radiotherapy (palliative radiotherapy for local pain control is excluded and the radiotherapy area do not include the proposed target lesion) and so on, or all relevant toxic reactions (except alopecia) have not been recovered.
  • Patients who are taking anticoagulant therapy (prophylactic use of low-dose aspirin or low molecular weight heparin is allowed).
  • Those who are expected to require systemic corticosteroids within 4 weeks prior to administration of BL0006 (low doses of corticosteroids are excluded, such as ≤ 10 mg prednisone daily or equivalent).
  • Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before screening, or any covid-19 vaccine within 2 weeks before screening.
  • Those who underwent major surgery within 4 weeks before screening, or plan to undergo major surgery during the study.
  • Those who are participating in other clinical studies, or have participated in any other interventional clinical studies within 4 weeks before screening.
  • Pregnant or lactating women.
  • Patients who are judged disqualified to join clinical studies by investigator due to any causes.

Trial locations and contacts

2 sites in 1 country.

Weixing Mao contact

+86-021-58383963

maoweixing@bestlinkbio.com

China2 sites, 2 recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

    Yanan Wang

    Yanan Wang

    Not yet recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Jia Fan

    Jia Fan

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BL0006 as a Single Agent in Patients With Advanced Solid Tumors

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.

Read the detailed description

This study consists of two parts: dose-escalation stage and dose-expansion stage.

The dose-escalation stage is designed to determine the maximum tolerated dose (MTD) and select recommended Phase 2 dose (RP2D) of BL0006 monotherapy. The dose-expansion stage will be conducted with selected doses to further evaluate the preliminary anti-tumor activity, safety and tolerability.

A total of approximately 19~66 patients will be enrolled in the study.

Approximately 13-30 patients will be enrolled into dose-escalation of BL0006 . A total of 6~36 patients each with advanced solid tumor will be evaluated in dose-expansion of BL0006.

Patients will continue to receive BL0006 as long as they are benefiting from treatment in the investigator's opinion and do not meet any other discontinuation criteria.

Being tested
BL0006

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL0006Drug

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

Study groups in NCT06247657
Study groupRoleWhat they receive
BL0006ExperimentalPatients will be administered BL0006 via intravenous infusion at the corresponding dose level on days 1 and 8 of a 21-days treatment cycle.
Receives: Drug: BL0006

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose(MTD)

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

    Measured: Throughout the study for approximately 2 years

  2. Recommended Phase II Dose(RP2D)

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

    Measured: Throughout the study for approximately 2 years

Secondary outcomes (7)

  1. Area under the plasma concentration-time curve (AUC)

    Area under the plasma concentration time curve

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

  2. Half life (t1/2)

    The elimination half-life time

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

  3. Disease Control Rate(DCR)

    DCR is defined as the proportion of subjects who achieve a Complete Response (CR) 、Partial Response (PR) or Stable Disease (SD) as assessed by RECIST v1.1

    Measured: Throughout the study for approximately 2 years

  4. Objective response rate(ORR)

    ORR is defined as the proportion of patients with the best responses of Complete Response (CR) and Partial Response (PR) observed after study treatment.

    Measured: Throughout the study for approximately 2 years

  5. Progression-Free Survival (PFS)

    PFS was defined as the the time from the start date of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Throughout the study for approximately 2 years

  6. Duration of overall response (DOR)

    DOR is defined as the time from the first documented CR or PR per RECIST v1.1 to disease recurrence or disease progression (PD) whichever occurs first.

    Measured: Throughout the study for approximately 2 years

  7. One-year Overall Survival rate (OS 12)

    OS 12 is defined as the proportion of patients alive at one year after the start date of study treatment.

    Measured: Throughout the study for approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start3 Jan 2024
  3. Primary completionOct 2024 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06247657
Sponsor's protocol ID
BL0006-101
Status last verified
Apr 2024
First submitted
10 Jan 2024
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BL0006 in people with Advanced Solid Tumor, run by Shanghai Best-Link Bioscience, LLC at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Weixing Mao (+86-021-58383963, maoweixing@bestlinkbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose(MTD) (time frame: Throughout the study for approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06247657.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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