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CancerPhase 1NCT06274437

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

A Phase 1 study testing BND-35, Nivolumab and Cetuximab in people with Cancer, run by Biond Biologics at 5 sites in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
BND-35, Nivolumab and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
5 sitesIsrael
Study dates
2 Jun 2024to 29 Apr 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Israel5 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah University Medical Center

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

About this study

Official title: A Phase 1, Dose Escalation and Dose Optimization Study of the Safety, Tolerability, and Anti-tumor Activity of BND-35 Administered Alone and in Combination With Nivolumab or With Cetuximab in Patients With Advanced Solid Tumors

This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab.

Read the detailed description

Estimated Study Duration:

Dose Escalation (Part 1): Approximately 34 months. Dose Optimization/Expansion (Part 2): Approximately 24 months.

Conditions
Cancer
Being tested
BND-35, Nivolumab, Cetuximab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BND-35Drug

    Also called Monoclonal antibody

    Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

  • NivolumabDrug

    Also called Opdivo

    Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

  • CetuximabDrug

    Also called Erbitux

    Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

Study groups in NCT06274437
Study groupRoleWhat they receive
BND-35 Dose Escalation (Sub-Part 1A)ExperimentalAccelerated titration followed by standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. BND-35 will be administered at escalating doses of 0.3 mg/kg to 20 mg/kg intravenously (IV), every 2 weeks (Q2W)
Receives: Drug: BND-35
BND-35 in Combination with Nivolumab Dose Escalation (Sub-Part 1B)ExperimentalStandard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. BND-35 will be administered at escalating doses of 3 mg/kg to 20 mg/kg intravenously (IV) every 2 weeks (Q2W). Nivolumab will be administered at a dose of 240 mg IV, every 2 weeks (Q2W).
Receives: Drug: BND-35; Drug: Nivolumab
BND-35 in Combination with Cetuximab Dose Escalation (Sub-Part 1C)ExperimentalStandard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. BND-35 will be administered at escalating doses of 3 mg/kg to 20 mg/kg intravenously (IV) every 2 weeks (Q2W). Cetuximab will be administered intravenously (IV) at a dose of 500 mg/m2, every 2 weeks (Q2W)
Receives: Drug: BND-35; Drug: Cetuximab
BND-35 in Combination with Nivolumab Dose Optimization (Sub-Part 2A)ExperimentalBND-35 dose optimization in combination with nivolumab. The indications for the combination cohorts will be selected following completion of Part 1. Enrollment will start after the recommended dose(s) of BND-35 have been determined based on data from Sub-Parts 1A, 1B, and 1C. Nivolumab will be administered at a dose of 240 mg IV, every 2 weeks (Q2W).
Receives: Drug: BND-35; Drug: Nivolumab
BND-35 in Combination with Cetuximab Dose Optimization (Sub-Part 2B)ExperimentalBND-35 dose optimization in combination with cetuximab. The indications for the combination cohorts will be selected following completion of Part 1. Enrollment will start after the recommended dose(s) of BND-35 have been determined based on data from Sub-Parts 1A, 1B, and 1C. Cetuximab will be administered intravenously (IV) at a dose of 500 mg/m2, every 2 weeks (Q2W)
Receives: Drug: BND-35; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Adverse event (AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.

    Measured: Through study completion, up to approximately 34 months

  2. Part 1: Proportion of patients who discontinued study treatment due to TEAEs

    Number of patients who discontinued study treatment due to TEAEs

    Measured: Through study completion, up to approximately 34 months

  3. Part 1: Incidence of TEAEs dose limiting toxicities (DLT)

    Incidence of TEAEs meeting protocol defined DLT criteria

    Measured: Up to 21 days in Cycle 1

  4. Part 2: Objective Response Rate (ORR) per RECIST v1.1

    Proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1

    Measured: Through study completion, up to approximately 24 months

  5. Part 2: Incidence of TEAEs and SAEs

    Adverse event (AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.

    Measured: Through study completion, an average of 24 months

Secondary outcomes (16)

  1. Part 1: Objective Response Rate (ORR) per RECIST v1.1

    Proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1

    Measured: Through study completion, up to approximately 34 months

  2. Part 1: Maximum observed plasma concentration (Cmax)

    Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

    Measured: Through study completion, up to approximately 34 months

  3. Part 1: Serum concentration at the end of the dosing interval (Ctrough)

    Ctrough is the lowest concentration of drug reached before the next dose was administered.

    Measured: Through study completion, up to approximately 34 months

  4. Part 1: Time of maximum observed serum concentration (Tmax)

    Tmax is time to reach maximum observed serum concentration obtained directly from the concentration versus time curve.

    Measured: Through study completion, up to approximately 34 months

  5. Part 1: Terminal elimination half-life (T1/2)

    Terminal half-life is the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.

    Measured: Through study completion, up to approximately 34 months

  6. Part 1: Area under the plasma concentration-time curve (AUC)

    AUC is the area under the concentration-time curve of drug

    Measured: Through study completion, up to approximately 34 months

  7. Part 1: Incidence of anti-drug antibodies (ADA)

    Number of participants with ADA positive results for BND-35

    Measured: Through study completion, up to approximately 34 months

  8. Part 2: Progression Free Survival (PFS)

    PFS is the time from the date of first dose of study drug to the date of first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Through study completion, up to approximately 24 months

  9. Part 2: PFS rate

    Percentage of participants with PFS, per RECIST v1.1

    Measured: At 3, 6, 9, and 12 months, and up to 24 months

  10. Part 2: Duration of Response

    Duration between first documentation of CR or PR to first documentation of disease progression or death due to any cause, whichever occurs first

    Measured: Through study completion, up to approximately 24 months

  11. Part 2: Maximum observed plasma concentration (Cmax)

    Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

    Measured: Through study completion, up to approximately 24 months

  12. Part 2: Serum concentration at the end of the dosing interval (Ctrough)

    Ctrough is the lowest concentration of drug reached before the next dose was administered.

    Measured: Through study completion, up to approximately 24 months

  13. Part 2: Time of maximum observed serum concentration (Tmax)

    Tmax is time to reach maximum observed serum concentration obtained directly from the concentration versus time curve.

    Measured: Through study completion, up to approximately 24 months

  14. Part 2: Terminal elimination half-life (T1/2)

    Terminal half-life is the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.

    Measured: Through study completion, up to approximately 24 months

  15. Part 2: Area under the plasma concentration-time curve (AUC)

    AUC is the area under the concentration-time curve of drug

    Measured: Through study completion, up to approximately 24 months

  16. Part 2: Incidence of anti-drug antibodies (ADA)

    Number of participants with ADA positive results for BND-35

    Measured: Through study completion, up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start2 Jun 2024
  3. Primary completion29 Apr 2026
  4. Study completion29 Apr 2026

Why it stopped: Study terminated due to strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06274437
Sponsor's protocol ID
BND-35-001
Status last verified
Jun 2026
First submitted
14 Feb 2024
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BND-35, Nivolumab and Cetuximab in people with Cancer, run by Biond Biologics at 5 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to strategic considerations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: Through study completion, up to approximately 34 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06274437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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