A Study of BA1202 in Patients With Advanced Solid Tumors

Trial Title: A Study of BA1202 in Patients With Advanced Solid Tumors

NCT ID: NCT05909241

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: BA1202
Description: BA1202 will be administered intravenously (IV) once every 3 weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the duration of administration was no more than 2 years. Part A: Patients will receive one of the following dosages of BA1202: 0.016mg, 0.08mg, 0.4mg, 1.6mg, 6.4mg, 19mg, 38mg, 56mg. Part B: Based on the data of part A, one or two dose levels will be discussed for further evaluation in part B.
Arm group label: BA1202

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.

Criteria for 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 v1.1. - ECOG score of < 2. - 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Hospital, Chinese Academy of Medical Sciences

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Huang Jing

Phone: 13301056087
Email: huangjingwg@163.com

Start date: August 16, 2023

Completion date: December 2026

Lead sponsor:
Agency: Shandong Boan Biotechnology Co., Ltd
Agency class: Industry

Source: Shandong Boan Biotechnology Co., Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05909241