BA1302 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: primary investigator
• Email: Guoj307@126.com
• Phone: 13911233048

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.