Advanced Solid TumorPhase 1NCT05886868
Phase I Study of BL0020, a Novel Anti-tumor Drug, in Adult Subjects With Advanced Solid Tumors
A Phase 1 study testing BL0020 in people with Advanced Solid Tumor, run by Shanghai Best-Link Bioscience, LLC at 4 sites in 2 countries.
Trial 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. 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?
- BL0020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 24 Oct 2023to Feb 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.
- Patients with histologically or cytologically confirmed, unresectable or metastatic advanced solid tumors that have failed despite standard therapy or have no standard therapy exists. TNBC, SCLC, and pancreatic cancer are preferred for the dose expansion phase.
- Patients with at least one measurable lesion per RECIST (v1.1) (applicable to the Part B: dose-expansion stage only).
- Note: Measurable lesions cannot be selected from the following sites in principle: having received prior radiotherapy or having received other local therapy. If a target lesion at a site that has received prior radiotherapy or other local therapy is the only optional lesion, the progression of the lesion shall be confirmed by the investigator.
- 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 3 months after the last dose of investigational product BL0020. Male subjects must also agree not to donate sperm from screening through at least 3 months after the dose of investigational product BL0020. Refer to Section 5.5 for more information on highly effective methods of contraception.
- 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 BL0020. 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. Refer to Section 5.5 for more information on highly effective methods of contraception.
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 3 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 Gilbert's syndrome disease.
- Patients with homozygous for UGT1A1*28 or UGT1A1*6 (only applicable to the patients in 3+3 dose-escalation cohorts at Part A).
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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% (if the LVEF data is available).
- 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 enrollment: 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 enrollment.
- 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 or HIV antibody test positive in screening.
- 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 1 weeks prior to enrollment.
- 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.
- 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.
- 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 > 1.5×ULN or creatinine clearance < 50 mL/min.
- Those who are known to be allergic to the active ingredient or excipients of the investigational product BL0020, or who have a predisposition to allergy.
- Patients with a history of an anaphylactic reaction to irinotecan, irinotecan liposome, or ≥ Grade 3 gastrointestinal toxicity to prior irinotecan, irinotecan liposome.
- Use of UGT1A1 inhibitors or inducers within 5 half-lives at the time of investigational product BL0020 administration, or planned use of UGT1A1 inhibitors or inducers within 2 weeks prior to administration of BL0020 (whichever is longer), or are expected to continue such therapy during the study.
- Anti-tumor therapy within 5 half-lives at the time of investigational product BL0020 administration, or anti-tumor therapy within 4 weeks prior to administration of BL0020 (whichever is shorter), therapy including chemotherapy, biologic therapy, immunotherapy, radiotherapy (except palliative radiotherapy 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 [≤ 100 mg/day] or low molecular weight heparin is allowed).
- Those who are expected to require systemic corticosteroids within 4 weeks prior to administration of BL0020 (low doses of corticosteroids are excluded, such as ≤ 20 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 enrollment or scheduled to receive during the study.
- Those who underwent major surgery within 4 weeks before enrollment, or plan to undergo major surgery during the study.
- Those who received other investigational drugs within 4 weeks or 5 half-lives of the investigational drugs (whichever is shorter) prior to enrollment.
- Pregnant or lactating women.
- Patients who are judged disqualified to join clinical studies by investigator due to any causes.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites, 1 recruiting
- Active, not recruiting
Sunshine Coast University Private Hospital
Birtinya, Queensland
- Active, not recruiting
Cancer Care Foundation Limited
Sydney, New South Wales
- Recruiting
Scientia Clinical Research
Sydney, New South Wales
Charlotte Lemech, charlotte.lemech@scientiaclinicalresearch.com.au
Charlotte Lemech
China1 site, 1 recruiting
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Ning Li, Lining@cicams.ac.cn
Ning Li
About this study
Official title: A Phase I, International, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BL0020 as A Single Agent in Patients With Advanced Solid Tumors
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
- Being tested
- BL0020
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL0020Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| BL0020 | Experimental | 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. Receives: Drug: BL0020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose(MTD)
Based on the incidence of Dose-Limiting Toxicity (DLT) of BL0020 in patients with advanced solid tumors, MTD is determined.
Measured: 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.
Measured: Throughout the study for approximately 2 years
Secondary outcomes (6)
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration time curve
Measured: Cycle 1 day 1 to Cycle 2 day 8
Half life (t1/2)
The elimination half-life time
Measured: Cycle 1 day 1 to Cycle 2 day 8
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
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
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start24 Oct 2023
- Primary completionJul 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai Best-Link Bioscience, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886868
- Sponsor's protocol ID
- BL0020-101
- Status last verified
- Nov 2023
- First submitted
- 24 May 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, International, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BL0020 as A Single Agent in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05886868
- Acronym / sponsor ID
- BL0020-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shanghai Best-Link Bioscience, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BL0020 | Experimental | Drug: BL0020Dose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Patients with histologically or cytologically confirmed, unresectable or metastatic advanced solid tumors that have failed despite standard therapy or have no standard therapy exists. TNBC, SCLC, and pancreatic cancer are preferred for the dose expansion phase.
- Patients with at least one measurable lesion per RECIST (v1.1) (applicable to the Part B: dose-expansion stage only).
- Note: Measurable lesions cannot be selected from the following sites in principle: having received prior radiotherapy or having received other local therapy. If a target lesion at a site that has received prior radiotherapy or other local therapy is the only optional lesion, the progression of the lesion shall be confirmed by the investigator.
Key exclusion criteria (39 listed)
- 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 3 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 Gilbert's syndrome disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL0020Dose 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. | Drug | BL0020 |
Primary outcome
Maximum Tolerated Dose(MTD)
Time frame: Throughout the study for approximately 2 years
Based on the incidence of Dose-Limiting Toxicity (DLT) of BL0020 in patients with advanced solid tumors, MTD is determined.
Recommended Phase II Dose(RP2D)
Time frame: Throughout the study for approximately 2 years
RP2D will be evaluated according to all the available safety, PK and efficacy data.
6 secondary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame: Cycle 1 day 1 to Cycle 2 day 8
Half life (t1/2)
Time frame: Cycle 1 day 1 to Cycle 2 day 8
Disease Control Rate(DCR)
Time frame: Throughout the study for approximately 2 years
Progression-Free Survival (PFS)
Time frame: Throughout the study for approximately 2 years
Duration of overall response (DOR)
Time frame: Throughout the study for approximately 2 years
Objective response rate(ORR)
Time frame: Throughout the study for approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BL0020 in people with Advanced Solid Tumor, run by Shanghai Best-Link Bioscience, LLC at 4 sites in 2 countries.
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 39 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, 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 (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?
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 29 Nov 2023.