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RECRUITING
NCT06274437
PHASE1

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

Sponsor: Biond Biologics

View on ClinicalTrials.gov

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

DRUG

BND-35

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

DRUG

Nivolumab

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

DRUG

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