Actively Recruiting
A Study of BA1202 in Patients With Advanced Solid Tumors
Led by Shandong Boan Biotechnology Co., Ltd · Updated on 2024-04-25
78
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, single-arm phase I study in patients with advanced solid tumors which consists of a dose escalation part (Part A) and a dose extension part (Part B). Part A aims to evaluate the safety and tolerability of BA1202, and determine the MTD. Part B will also evaluate the preliminary efficacy of BA1202.
CONDITIONS
Official Title
A Study of BA1202 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily sign an informed consent form and agree to study restrictions
- Part A: Patients with confirmed advanced or metastatic solid tumors who have progressed on standard treatment, are intolerant to it, or have no standard treatment available
- Part B: Patients with confirmed colorectal, non-small cell lung, pancreatic, or gastric cancer who have progressed on standard treatment, are intolerant to it, or have no standard treatment available (specific cohort determined after dose escalation data)
- Part B: Tumors with high CEACAM5 expression (≥ 20% of tumor cells with IHC 2+ or 3+)
- Life expectancy of at least 3 months
- At least one evaluable lesion in Part A and one measurable lesion in Part B according to RECIST v1.1
- ECOG performance status less than 2
- Adequate blood counts: neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L
- Liver function within limits: total bilirubin ≤ 1.5 x upper limit normal (ULN), ALT and AST ≤ 2.5 x ULN (or ≤ 5 x ULN if liver metastases)
- Kidney function within limits: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- Coagulation tests within limits: INR PT ≤ 1.5 x ULN, APTT ≤ 1.5 x ULN
- Negative pregnancy test for women with fertility potential, who agree to use reliable contraception during the study and for 6 months after last dose
You will not qualify if you...
- Other cancers within 5 years before screening, except cured stage Ib or lower cervical cancer and non-invasive basal or squamous cell skin cancer
- Active or persistent infections requiring intravenous treatment
- History of severe heart or brain blood vessel disease
- Autoimmune diseases needing medication control or at risk of recurrence
- Received radiotherapy (except palliative for bone metastases), chemotherapy, targeted therapy, immunotherapy, cell therapy, or investigational cancer treatments within 4 weeks before starting BA1202, unless chemotherapy or targeted therapy was given less than 4 weeks after first BA1202 dose and has cleared at least 5 half-lives
- Previous CEA targeting therapy including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, or CAR-T
- Allergy to BA1202, Obinutuzumab components, or other monoclonal antibodies
- Women who are pregnant, planning pregnancy, or breastfeeding
- Any other conditions the investigator considers unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here