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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05886868




Registration number
NCT05886868
Ethics application status
Date submitted
24/05/2023
Date registered
2/06/2023
Date last updated
29/11/2023

Titles & IDs
Public title
Phase I Study of BL0020, a Novel Anti-tumor Drug, in Adult Subjects With Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
BL0020-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BL0020

Experimental: 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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose(MTD)
Timepoint [1] 0 0
Throughout the study for approximately 2 years
Primary outcome [2] 0 0
Recommended Phase II Dose(RP2D)
Timepoint [2] 0 0
Throughout the study for approximately 2 years
Secondary outcome [1] 0 0
Area under the plasma concentration-time curve (AUC)
Timepoint [1] 0 0
Cycle 1 day 1 to Cycle 2 day 8
Secondary outcome [2] 0 0
Half life (t1/2)
Timepoint [2] 0 0
Cycle 1 day 1 to Cycle 2 day 8
Secondary outcome [3] 0 0
Disease Control Rate(DCR)
Timepoint [3] 0 0
Throughout the study for approximately 2 years
Secondary outcome [4] 0 0
Progression-Free Survival (PFS)
Timepoint [4] 0 0
Throughout the study for approximately 2 years
Secondary outcome [5] 0 0
Duration of overall response (DOR)
Timepoint [5] 0 0
Throughout the study for approximately 2 years
Secondary outcome [6] 0 0
Objective response rate(ORR)
Timepoint [6] 0 0
Throughout the study for approximately 2 years

Eligibility
Key inclusion criteria
1. Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consent form.
2. Aged = 18 years, male and female.
3. 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.
4. 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.
5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.
6. Life expectancy period = 12 weeks.
7. 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.
8. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis.
2. 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.
3. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.
4. Patients with a history of allogeneic transplantation of organs, bone marrow or stem cell.
5. Patients with Gilbert's syndrome disease.
6. Patients with homozygous for UGT1A1*28 or UGT1A1*6 (only applicable to the patients in 3+3 dose-escalation cohorts at Part A).
7. 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.
8. 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.
9. Known history of clinically significant active Chronic Obstructive Pulmonary Disease (COPD), or other moderate-to-severe chronic respiratory illness present within 6 months.
10. Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive in screening.
11. 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.
12. Active infections requiring antibiotic intravenous therapy within 1 weeks prior to enrollment.
13. 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.
14. Those who received blood transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to screening.
15. 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.
16. 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.
17. Patients with a history of an anaphylactic reaction to irinotecan, irinotecan liposome, or = Grade 3 gastrointestinal toxicity to prior irinotecan, irinotecan liposome.
18. 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.
19. 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.
20. Patients who are taking anticoagulant therapy (prophylactic use of low-dose aspirin [= 100 mg/day] or low molecular weight heparin is allowed).
21. 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).
22. 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.
23. Those who underwent major surgery within 4 weeks before enrollment, or plan to undergo major surgery during the study.
24. Those who received other investigational drugs within 4 weeks or 5 half-lives of the investigational drugs (whichever is shorter) prior to enrollment.
25. Pregnant or lactating women.
26. Patients who are judged disqualified to join clinical studies by investigator due to any causes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Cancer Care Foundation Limited - Sydney
Recruitment hospital [2] 0 0
Scientia Clinical Research - Sydney
Recruitment hospital [3] 0 0
Sunshine Coast University Private Hospital - Birtinya
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Birtinya
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Best-Link Bioscience, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05886868
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Weixing Mao
Address 0 0
Country 0 0
Phone 0 0
021-58383963
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05886868