New cancer drug combo tested in tiny trial – but halted early
NCT ID NCT06274437
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested an experimental drug called BND-35, alone or combined with nivolumab or cetuximab, in 12 people with advanced solid tumors that had stopped responding to standard treatments. The main goal was to check safety and find the right dose. The study was terminated early, so we have limited information on how well it worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BND-35 (an experimental antibody), nivolumab (Opdivo), and cetuximab (Erbitux)
- What this could lead to
- If successful, this could point toward a new treatment option for advanced cancers that have not responded to standard therapies.
- What could go wrong
- This was a very early phase 1 trial with only 12 participants and has been terminated, so results are limited. The drug may not prove effective or safe in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
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Apr 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hadassah University Medical Center
Jerusalem, 91120, Israel
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Rabin Medical Center
Petah Tikva, 49100, Israel
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Rambam Health Care Campus
Haifa, 3109601, Israel
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Sheba Medical Center
Ramat Gan, 52621, Israel
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Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
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