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BND-35 Dose Escalation (Sub-Part 1A) for Cancer

Phase 1
Recruiting
Research Sponsored by Biond Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3, 6, 9, and 12 months, and up to 24 months
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3, 6, 9, and 12 months, and up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3, 6, 9, and 12 months, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Incidence of TEAEs dose limiting toxicities (DLT)
Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Part 1: Proportion of patients who discontinued study treatment due to TEAEs
+2 more
Secondary study objectives
Part 1: Area under the plasma concentration-time curve (AUC)
Part 1: Incidence of anti-drug antibodies (ADA)
Part 1: Maximum observed plasma concentration (Cmax)
+13 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: BND-35 in Combination with Nivolumab Dose Optimization (Sub-Part 2A)Experimental Treatment2 Interventions
BND-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).
Group II: BND-35 in Combination with Nivolumab Dose Escalation (Sub-Part 1B)Experimental Treatment2 Interventions
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 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).
Group III: BND-35 in Combination with Cetuximab Dose Optimization (Sub-Part 2B)Experimental Treatment2 Interventions
BND-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)
Group IV: BND-35 in Combination with Cetuximab Dose Escalation (Sub-Part 1C)Experimental Treatment2 Interventions
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 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)
Group V: BND-35 Dose Escalation (Sub-Part 1A)Experimental Treatment1 Intervention
Accelerated 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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
Cetuximab
2011
Completed Phase 3
~2480

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Who is running the clinical trial?

Biond BiologicsLead Sponsor
1 Previous Clinical Trials
456 Total Patients Enrolled
Natalia AshtamkerStudy DirectorBiond Bio
~187 spots leftby Sep 2027
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