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

Sponsor
Biond Biologics
Study ID
NCT06274437
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BND-35 — DRUG
    Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
  • Nivolumab — DRUG
    Pharmaceutical form: Solution for infusion; Route of administration: Intravenous
  • Cetuximab — DRUG
    Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

Study Details

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.

Key Dates

Start date
Jun 2, 2024
Status verified
Aug 2024
Primary completion
Sep 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
280 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BND-35 Dose Escalation (Sub-Part 1A)
    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)
  • Experimental: BND-35 in Combination with Nivolumab Dose Escalation (Sub-Part 1B)
    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).
  • Experimental: BND-35 in Combination with Cetuximab Dose Escalation (Sub-Part 1C)
    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)
  • Experimental: BND-35 in Combination with Nivolumab Dose Optimization (Sub-Part 2A)
    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).
  • Experimental: BND-35 in Combination with Cetuximab Dose Optimization (Sub-Part 2B)
    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)

Primary Outcome Measure

Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Through study completion, up to approximately 34 months ]

Central Contacts

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