A Phase 1 interventional study of BA1202 in Advanced Solid Tumor, sponsored by Shandong Boan Biotechnology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Shandong Boan Biotechnology Co., Ltd · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 78 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Shandong Boan Biotechnology Co., Ltd is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BA1202 is a bispecific antibody targeting CEA and CD3.
Drug: BA1202
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.
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.
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.)
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.)
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.)
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.)
Objective Response Rate (ORR)
Time frame: up to 2 years
Disease Control Rate (DCR)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Time frame: up to 2 years
Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: Cycle 1: Day 1, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 5 Day 1; Cycle 6 Day 1; EOT (end of treatment) visit. (Each cycle is 21 days.)
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Shandong Boan Biotechnology Co., Ltd