A Study of BND-35 in Participants With Advanced Solid Tumors

Launched by BIOND BIOLOGICS · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BND-35 for patients with advanced solid tumors, which are types of cancer that cannot be surgically removed or have spread to other parts of the body. The trial is designed to see how safe BND-35 is, how well it works on tumors, and how it performs when combined with other treatments like nivolumab or cetuximab. The study is divided into two parts: the first part will explore different ways to give BND-35, and the second part will focus on finding the best doses to use with the other medications.

To be eligible for this trial, participants must have a confirmed diagnosis of certain types of cancer and should not have responded to standard treatments. They should also be in reasonably good health, meaning they can carry out daily activities without much difficulty. Patients will have regular check-ups during the trial to monitor their health and how well the treatment is working. It's important to note that some patients, such as those with active autoimmune diseases or recent serious health issues, may not be able to participate. This trial offers hope for those who have limited options left in their cancer treatment journey.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy
• • Histologic confirmation of malignancy
• • Measurable disease per RECIST v1.1
• • Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
• • Participants must have adequate organ function as defined by laboratory tests
• • Part 1: Following tumor types: Breast cancer, cholangiocarcinoma, colorectal cancer, adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, melanoma, ovarian cancer, renal cell carcinoma, pancreatic adenocarcinoma, soft tissue sarcomas
• Exclusion Criteria:
• • Active, known or suspected autoimmune disease
• • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
• • Brain or leptomeningeal metastases
• • Known history of positive test for HIV or known AIDS
• • Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV)
• • Participants after solid organ or allogeneic hematopoietic stem cell transplant
• • History of life-threatening toxicity related to prior immune therapy
• • History of life-threatening toxicity related to prior cetuximab or other anti-epidermal growth factor receptor antibodies (for Sub-Part 1C)
• • Unstable or deteriorating cardiovascular disease within the previous 6 months
• • Any major surgery within 4 weeks of study drug administration
• • Prior immune therapy treatments, unless at least 4 weeks have elapsed from last dose
• • Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from last dose
• • Use of other investigational drugs within 28 days
• • Prior treatment with immunoglobulin-like transcripts (ILT3)-targeting agents
• • Administration of a live attenuated vaccine within 28 days