BA1302 for advanced solid tumors
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid Malignancies
This trial will test whether BA1302 is safe and helps people with advanced solid tumors, including non-small cell lung cancer, pancreatic cancer, breast cancer, and melanoma, who have progressed after or cannot have standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 167 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shandong Boan Biotechnology Co., Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06596915 on ClinicalTrials.gov |
What this trial studies
This first-in-human, open-label Phase I study administers BA1302 to adults with advanced, unresectable, or metastatic solid tumors to characterize safety, tolerability, pharmacokinetics, immunogenicity, and preliminary signs of efficacy. The design includes a dose-escalation phase (Part A) to identify safe dose levels followed by tumor-specific dose-expansion cohorts (Part B) in melanoma, breast cancer, non-small cell lung cancer, and pancreatic adenocarcinoma. Eligible patients must have measurable disease by RECIST v1.1, an ECOG performance status of 0–1, and be able to provide tumor tissue for biomarker analysis. The trial is multicenter and open-label and is sponsored by Shandong Boan Biotechnology with at least one site at Beijing Cancer Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed metastatic or unresectable NSCLC, pancreatic adenocarcinoma, breast cancer, or melanoma who have progressed on or are intolerant of standard therapies, have measurable disease, ECOG 0–1, and can provide tumor tissue.
Not a fit: Patients with other recent malignancies within the past five years, poor performance status (ECOG >1), or who cannot provide required tumor tissue are unlikely to be eligible or benefit from this early-phase trial.
Why it matters
Potential benefit: If BA1302 proves safe and active, it could become a new treatment option that controls cancer growth for some patients with advanced solid tumors.
How similar studies have performed: As a first-in-human trial, BA1302 is untested in people, and while other early-phase immuno-oncology and targeted agents have shown responses in some tumor types, success is not guaranteed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. 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. 1. Part A: Advanced malignant solid tumors; 2. Part B: Metastatic melanoma, Advanced breast cancer, Advanced Non-small cell lung cancer (NSCLC), Advanced pancreatic adenocarcinoma. * 2.Participants should be able to provide adequate tumor tissue for biomarker analysis * 3.ECOG Performance Status ≤ 1. * 4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1) Exclusion Criteria: * 1\. Malignant disease within 5 years prior to the first dose of investigational drug other than that being treated in this study. Except completely resected basal cell carcinoma, cutaneous squamous cell skin carcinoma and papillary thyroid carcinoma and completely resected carcinoma in situ of any type. * 2\. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC medication or other anti-cancer treatment within 28 days prior to the first dose. * 3.History of severe hypersensitivity reactions to any ingredient of study drugs. * 4.Pregnant or lactating women. * 5.Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
Where this trial is running
Beijing
- Beijing Cancer Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: primary investigator
- Email: Guoj307@126.com
- Phone: 13911233048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.