Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009
Phase 1
Recruiting
- Conditions
- Locally Advanced/Metastatic Solid Tumours
- Interventions
- Drug: BAT8009 for Injection
- Registration Number
- NCT05405621
- Lead Sponsor
- Bio-Thera Solutions
- 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 (RP2D).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 BAT8009 for Injection Experimental: BAT8009 for Injection 0.6 mg/kg (frequency: Q3W) Cohort 2 BAT8009 for Injection Drug: BAT8009 for Injection 1.2 mg/kg (frequency: Q3W) Cohort 3 BAT8009 for Injection Drug: BAT8009 for Injection 2.4 mg/kg (frequency: Q3W) Cohort 4 BAT8009 for Injection Drug: BAT8009 for Injection 3.6mg/kg (frequency: Q3W) Cohort 5 BAT8009 for Injection Drug: BAT8009 for Injection 4.8mg/kg (frequency: Q3W) Cohort6 BAT8009 for Injection Drug: BAT8009 for Injection 6.0mg/kg (frequency: Q3W) Cohort 7 BAT8009 for Injection Drug: BAT8009 for Injection 7.2mg/kg (frequency: Q3W) Cohort 8 BAT8009 for Injection Drug: BAT8009 for Injection 8.4mg/kg (frequency: Q3W)
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity(DLT) A minimum of 21 days after first dose of BAT8009 A DLT is defined as a toxicity occurring during the DLT observation period
- Secondary Outcome Measures
Name Time Method Cmax (Maximum serum concentration) 126 days after first dosing Maximum observed plasma or serum concentration
Immunogenicity 126 days after first dosing Presence of ADAs / neutralizing antibodies (NAbs).
AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration 126 days after first dosing area under the serum concentration versus time curve from time zero to infinity and to time λ
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China