A Study of BA1202 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShandong Boan Biotechnology Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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+).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BA1202
Treatment groups
78 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov