Phase I Study of BL0020, a Novel Anti-tumor Drug, in Adult Subjects With Advanced Solid Tumors

NCT05886868 | Unknown Phase 1 FDA Drug

• 1 other identifier: BL0020-101
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 4

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose(MTD)

  Based on the incidence of Dose-Limiting Toxicity (DLT) of BL0020 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 (6)

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

  Cycle 1 day 1 to Cycle 2 day 8

• Half life (t1/2)

  Cycle 1 day 1 to Cycle 2 day 8

• Disease Control Rate(DCR)

  Throughout the study for approximately 2 years

• Progression-Free Survival (PFS)

  Throughout the study for approximately 2 years

• Duration of overall response (DOR)

  Throughout the study for approximately 2 years

Study Arms (1)

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.

Drug: BL0020

Interventions

BL0020 DRUG

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.

BL0020

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.
• 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.
• 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.

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 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).
• 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.

Sponsors & Collaborators

• Shanghai Best-Link Bioscience, LLC: lead

Study Sites (4)

Cancer Care Foundation Limited

Sydney, New South Wales, Australia

ACTIVE NOT RECRUITING

Scientia Clinical Research

Sydney, New South Wales, Australia

RECRUITING

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia

ACTIVE NOT RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Central Study Contacts

Weixing Mao

CONTACT

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: May 24, 2023
• First Posted: June 2, 2023
• Study Start: October 24, 2023
• Primary Completion: July 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

AU (3); CN (1)