Clinical trial NCT05405621: Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009
Official title: A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Locally Advanced/Metastatic Solid Tumours
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2022-06-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
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:

1. Females who are pregnant or nursing.
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.

Primary outcomes:
measure: Dose-limiting toxicity(DLT)
timeFrame: A minimum of 21 days after first dose of BAT8009
Secondary outcomes:
measure: Cmax (Maximum serum concentration)
timeFrame: 126 days after first dosing
measure: Immunogenicity
timeFrame: 126 days after first dosing
measure: AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration
timeFrame: 126 days after first dosing
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: