Evaluating BND-35 for advanced solid tumors
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 study is testing a new treatment called BND-35, alone and with other drugs, to see if it can help people with advanced solid tumors that haven't responded to standard therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biond Biologics Industry-sponsored |
| Drugs / interventions | cetuximab, nivolumab |
| Locations | 5 sites (Haifa and 4 other locations) |
| Trial ID | NCT06274437 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter study aims to assess the safety, tolerability, and preliminary anti-tumor activity of BND-35, both alone and in combination with nivolumab or cetuximab, in patients with advanced solid tumors. The study consists of a dose escalation phase, where different doses of BND-35 will be tested, and a dose optimization phase to determine the most effective doses. Participants will include those with unresectable or metastatic cancers who have not responded to or are not eligible for standard therapies. The study will last approximately 58 months in total.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable or metastatic solid tumors who have histologically confirmed malignancies and are refractory to standard treatments.
Not a fit: Patients with active autoimmune diseases or those requiring systemic immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers that are resistant to existing therapies.
How similar studies have performed: While this approach is novel, similar studies involving combination therapies for advanced cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Haifa and 4 other locations
- Rambam Health Care Campus — Haifa, Israel (Recruiting)
- Hadassah University Medical Center — Jerusalem, Israel (Recruiting)
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Natalia Ashtamker, MD
- Email: natalia@biondbio.com
- Phone: +972548886441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.