Testing BA1202 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.