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New cancer drug combo tested in tiny trial – but halted early

NCT ID NCT06274437

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

  • Hadassah University Medical Center

    Jerusalem, 91120, Israel

  • Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

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