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Clinical Trials in China / NCT06596915
Recruiting Phase 1

Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

NCT06596915 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Boan Biotechnology Co., Ltd
Phase
Phase 1
Started
2024-09-11
Last updated
2025-06-06

Condition(s) studied

Non-Small Cell Lung CancerPancreatic AdenocarcinomaBreast CancerMelanoma

Investigational drug(s) / intervention(s)

BA1302

BA1302: BA1302 administered intravenously

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06596915 on ClinicalTrials.gov ↗ ← All trials in China