Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009
NCT ID: NCT05405621
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
48 participants
INTERVENTIONAL
2022-08-02
2024-12-31
Brief Summary
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* To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours.
* To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Experimental: BAT8009 for Injection 0.6 mg/kg (frequency: Q3W)
BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Cohort 2
Drug: BAT8009 for Injection 1.2 mg/kg (frequency: Q3W)
BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Cohort 3
Drug: BAT8009 for Injection 2.4 mg/kg (frequency: Q3W)
BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Cohort 4
Drug: BAT8009 for Injection 3.6mg/kg (frequency: Q3W)
BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Cohort 5
Drug: BAT8009 for Injection 4.8mg/kg (frequency: Q3W)
BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Cohort6
Drug: BAT8009 for Injection 6.0mg/kg (frequency: Q3W)
BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Cohort 7
Drug: BAT8009 for Injection 7.2mg/kg (frequency: Q3W)
BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Cohort 8
Drug: BAT8009 for Injection 8.4mg/kg (frequency: Q3W)
BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Interventions
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BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged ≥ 18 years and ≤ 75 years.
3. Life expectancy ≥ 3 months.
4. ECOG performance status ≤ 1.
5. Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy.
6. Has measurable or evaluable disease per RECIST v1.1.
7. Adequate haematological, liver, kidney, cardiac and coagulation function.
8. Is willing to provide pre-existing diagnostic or resected tumour samples (if available).
9. Female patients must: Be of non-child-bearing potential; Male patients must: be willing not to donate sperm.
10. Must agree to adhere to the current state and national advice regarding minimising exposure to COVID-19 from the first Screening visit until the end of study (28-day Safety Follow-up Visit).
Exclusion Criteria
2. Receiving concurrent anticancer therapy or investigational therapy.
3. Persisting AEs that are \> Grade 1 from prior antitumour treatment as per CTCAE v5.0.
4. Patients with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.
5. Had major surgery within 28 days of the Screening visit.
6. History of autologous transplantation ≤ 3 months.
7. History of severe infection deemed clinically significant by the PI or designee within 4 weeks.
8. History of human immunodeficiency virus (HIV) infection.
9. Active hepatitis B or C.
10. History of a Grade 3 or Grade 4 allergic reaction to treatment with other antibodies.
18 Years
75 Years
ALL
No
Sponsors
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Bio-Thera Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Li Zhang, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Li Zhang
Role: primary
Other Identifiers
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BAT-8009-001-CR
Identifier Type: -
Identifier Source: org_study_id
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