Status:
UNKNOWN
Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009
Lead Sponsor:
Bio-Thera Solutions
Conditions:
Locally Advanced/Metastatic Solid Tumours
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Primary objectives: * 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 (RP2...
Detailed Description
This is a first-in-human (FIH), multicentre, open-label, Phase 1 dose escalation and dose expansion study of BAT8009 (a B7H3-targeting antibody-drug conjugate) in patients with advanced solid tumours.
Eligibility Criteria
Inclusion
- Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
- Aged ≥ 18 years and ≤ 75 years.
- Life expectancy ≥ 3 months.
- ECOG performance status ≤ 1.
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy.
- Has measurable or evaluable disease per RECIST v1.1.
- Adequate haematological, liver, kidney, cardiac and coagulation function.
- Is willing to provide pre-existing diagnostic or resected tumour samples (if available).
- Female patients must: Be of non-child-bearing potential; Male patients must: be willing not to donate sperm.
- 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
- Females who are pregnant or nursing.
- Receiving concurrent anticancer therapy or investigational therapy.
- Persisting AEs that are \> Grade 1 from prior antitumour treatment as per CTCAE v5.0.
- Patients with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.
- Had major surgery within 28 days of the Screening visit.
- History of autologous transplantation ≤ 3 months.
- History of severe infection deemed clinically significant by the PI or designee within 4 weeks.
- History of human immunodeficiency virus (HIV) infection.
- Active hepatitis B or C.
- History of a Grade 3 or Grade 4 allergic reaction to treatment with other antibodies.
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05405621
Start Date
August 2 2022
End Date
December 1 2024
Last Update
October 27 2022
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China