Phase
Condition
Cancer
Treatment
BND-35
Cetuximab
Nivolumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with unresectable or metastatic disease who are refractory to or are notcandidates 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 orgastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head andneck, non-small cell lung cancer, melanoma, ovarian cancer, renal cell carcinoma,pancreatic adenocarcinoma, soft tissue sarcomas
Exclusion
Exclusion Criteria:
Active, known or suspected autoimmune disease
Condition requiring systemic treatment with either corticosteroids or otherimmunosuppressive 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 otheranti-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 elapsedfrom 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
Study Design
Study Description
Connect with a study center
Rambam Health Care Campus
Haifa, 3109601
IsraelActive - Recruiting
Hadassah University Medical Center
Jerusalem, 91120
IsraelActive - Recruiting
Rabin Medical Center
Petah Tikva, 49100
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, 52621
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
IsraelActive - Recruiting
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