NCT05909241RecruitingPhase 1
A Multicenter, Open-label, Single-arm, Dose Escalation and Expansion Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1202 in Patients With Advanced Solid Tumors
Shandong Boan Biotechnology Co., Ltd1 site in 1 country78 target enrollmentStarted: August 16, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Incidence and severity of adverse events (AEs)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who voluntarily sign an IRB-approved informed consent form, and are willing to abide by the restrictions of the study.
- •Part A: Patients with histologically and/or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.
- •Part B: Patients with histologically and/or cytologically confirmed colorectal cancer, non-small cell lung cancer, pancreatic cancer, gastric cancer, who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.（Specific cohort will be determined after data of dose escalation phase is obtained）
- •Part B: High expression of CEACAM5 (defined as ≥ 20% of tumor cells with IHC 2+ and/or 3+).
- •Life expectancy of at least 3 months.
- •At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.
- •ECOG score of <
- •Absolute neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L.
- •Total bilirubin ≤ 1.5×ULN, ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases).
- •Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥50 mL/min.
- •International normalized ratio (INR) prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.
- •Blood pregnancy test results were negative for female patients with fertility potential. Patients with fertility potential must agree to use a reliable method of contraception with their sexual partners during the study period and at least 6 months after the last administration.
Exclusion Criteria
- •Other malignancies within 5 years prior to screening (other than cured stage Ib or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer).
- •Has a persistent or active infection that requires intravenous treatment.
- •History of severe cardiovascular and cerebrovascular disease.
- •Patients with autoimmune diseases requiring drug control or at risk of recurrence of autoimmune diseases.
- •Received any radiotherapy (other than palliative radiotherapy for bone metastases), chemotherapy, targeted therapy, immunotherapy, cell therapy, or other investigational anticancer agents within 4 weeks prior to first dose of BA1202, unless chemotherapy or targeted therapy is less than 4 weeks after first dose but has eluted ≥5 half-lives.
- •Have received any previous CEA targeting therapy, including but not limited to monoclonal antibodies, bisspecific antibodies, antibody-coupled drugs (ADCs), chimeric antigen receptor T cells (CAR-T), etc.
- •A history of allergy to BA1202 or any component of Obinutuzumab, or to other monoclonal antibodies.
- •Women are planning to become pregnant or are pregnant or breastfeeding.
- •Other conditions considered unsuitable for enrollment by the investigator.
Arms & Interventions
BA1202
Experimental
BA1202 is a bispecific antibody targeting CEA and CD3.
Intervention: BA1202 (Drug)
Outcomes
Primary Outcomes
Incidence and severity of adverse events (AEs)
Time Frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
Secondary Outcomes
- Disease Control Rate (DCR)(up to 2 years)
- Minimum Concentration (Cmin) of BA1202(Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.))
- Area under the curve (AUC) of BA1202(Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.))
- Progression-Free Survival (PFS)(up to 2 years)
- Overall Survival (OS)(up to 2 years)
- Time of maximum concentration (Tmax) of BA1202(Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.))
- Maximum Concentration (Cmax) of BA1202(Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.))
- Objective Response Rate (ORR)(up to 2 years)
- Duration of Response (DOR)(up to 2 years)
- Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab)(Cycle 1: Day 1, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 5 Day 1; Cycle 6 Day 1; EOT (end of treatment) visit. (Each cycle is 21 days.))
Investigators
Study Sites (1)
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