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

NCT06274437 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-08-07

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Biond Biologics

    lead INDUSTRY

Principal Investigators

  • Natalia Ashtamker · Biond Bio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-02
Primary Completion
2027-09-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274437 on ClinicalTrials.gov