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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
BA1202
DrugBA1202 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.
Treatment groups
78 Participants
are divided into 1 treatment groupGroup A: BA1202Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
1
Maximum Concentration (Cmax) of BA1202
Time frame
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.)2
Area under the curve (AUC) of BA1202
Time frame
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.)3
Minimum Concentration (Cmin) of BA1202
Time frame
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.)4
Time of maximum concentration (Tmax) of BA1202
Time frame
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.)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov