Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

Launched by SHANDONG BOAN BIOTECHNOLOGY CO., LTD · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called BA1302 for patients with advanced solid tumors, including non-small cell lung cancer, pancreatic cancer, breast cancer, and melanoma. The main goals of the study are to see how safe the drug is, how well it works, and how the body processes it. The trial has two parts: the first part will gradually increase the dose to find the best amount, while the second part will focus on specific types of cancer to gather more information about its effects.

To be eligible for this trial, participants should have a confirmed diagnosis of an advanced cancer that cannot be surgically removed, and they must have either not responded to standard treatments or not have any other options available. Participants will need to provide a tissue sample for testing and should be in good enough health to participate. During the trial, they can expect regular check-ups and monitoring to assess their health and the treatment's impact. It's important to note that individuals who have recently received other cancer treatments or have certain medical conditions may not be able to join the study.

Gender

ALL

Eligibility 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.