Testing BA1202 in patients with advanced solid tumors

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

This study is testing a new treatment called BA1202 to see if it is safe and effective for people with advanced solid tumors who haven't had success with other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shandong Boan Biotechnology Co., Ltd (Industry-sponsored)
• Drugs / interventions: Obinutuzumab, CAR-T, chimeric antigen receptor, chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT05909241 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, single-arm phase I study evaluates the safety and tolerability of BA1202 in patients with advanced solid tumors. The study consists of two parts: Part A focuses on dose escalation to determine the maximum tolerated dose (MTD), while Part B assesses the preliminary efficacy of BA1202 in specific cancer types. Eligible patients must have progressed on standard-of-care treatments or be intolerant to them. The study aims to provide insights into the potential therapeutic benefits of BA1202 for these patients.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors who have progressed on standard treatments and have high expression of CEACAM5.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard-of-care treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced solid tumors, but the specific efficacy of BA1202 remains to be established.

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.

Where this trial is running

Beijing

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)

Conditions Advanced Solid Tumor