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 enrollmentAugust 16, 2023

ConditionsAdvanced Solid Tumor

InterventionsBA1202

DrugsBA1202

Overview

Phase: Phase 1
Intervention: BA1202
Conditions: Advanced Solid Tumor
Sponsor: Shandong Boan Biotechnology Co., Ltd
Enrollment: 78
Locations: 1
Primary Endpoint: Incidence and severity of adverse events (AEs)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 16, 2023

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shandong Boan Biotechnology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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.

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

BA1202 is a bispecific antibody targeting CEA and CD3.

Intervention: BA1202

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.))