A Phase 1 interventional study of BA1302 in Non-Small Cell Lung Cancer, Pancreatic Adenocarcinoma and Breast Cancer, sponsored by Shandong Boan Biotechnology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Shandong Boan Biotechnology Co., Ltd · Phase 1, Interventional, and Treatment
This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 167 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma 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.
Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed. Patients who have progressed on or after standard therapy, or are intolerant of standard therapy, or have no appropriate standard therapy available.
Exclusion Criteria:
Drug: BA1302
BA1302 administered intravenously
Number of participants with dose limiting toxicities
Time frame: Up to 21 days
adverse events
Time frame: Through 28 days after the last study treatment
Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t)
Time frame: Up to approximately 1 years
AUC from time zero to infinity (AUC0-inf)
Time frame: Up to approximately 1 years
Maximum serum concentration (Cmax)
Time frame: Up to approximately 1 years
Elimination half-life (t1/2)
Time frame: Up to approximately 1 years
Area under the concentration-time curve (AUC) at steady state
Time frame: Up to approximately 1 years
Incidence of anti-drug antibodies (ADA)
Time frame: Up to approximately 1 years
Objective response rate (ORR)
Time frame: Up to approximately 1 years
Duration of objective response (DOR)
Time frame: Up to approximately 1 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Shandong Boan Biotechnology Co., Ltd