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A Study of BND-35 in Participants With Advanced Solid Tumors
Sponsor: Biond Biologics
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. 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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2024-06-02
Completion Date
2027-11
Last Updated
2024-08-07
Healthy Volunteers
No
Conditions
Interventions
BND-35
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Nivolumab
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Cetuximab
Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
Locations (5)
Rambam Health Care Campus
Haifa, Israel
Hadassah University Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel