Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Non-Small Cell Lung Cancer, Pancreatic Adenocarcinoma, Breast Cancer, Melanoma

In brief

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).

Key facts

Study ID

NCT06596915

Run by

Shandong Boan Biotechnology Co., Ltd

People needed

167

Starts

2024-09-11

Expected to finish

2026-12-30

Last updated by the study team

2025-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Part A: Advanced malignant solid tumors;
• 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)

You may not qualify if…

• 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 is running

• Beijing Cancer Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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