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

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• Neoplasms 9,365

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 12 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Lead sponsor

This is the only study on the registry with Biond Biologics as lead sponsor.

Study 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)

  Drug: BND-35

• 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).

  Drug: BND-35 · Drug: Nivolumab

• 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)

  Drug: BND-35 · Drug: Cetuximab

• 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).

  Drug: BND-35 · Drug: Nivolumab

• 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)

  Drug: BND-35 · Drug: Cetuximab

Interventions

• DrugBND-35

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

  Also known as: Monoclonal antibody

• DrugNivolumab

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

  Also known as: Opdivo

• DrugCetuximab

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

  Also known as: Erbitux

Primary outcomes

1. Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

   Adverse event (AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.

   Time frame: Through study completion, up to approximately 34 months

2. Part 1: Proportion of patients who discontinued study treatment due to TEAEs

   Number of patients who discontinued study treatment due to TEAEs

   Time frame: Through study completion, up to approximately 34 months

3. Part 1: Incidence of TEAEs dose limiting toxicities (DLT)

   Incidence of TEAEs meeting protocol defined DLT criteria

   Time frame: Up to 21 days in Cycle 1

4. Part 2: Objective Response Rate (ORR) per RECIST v1.1

   Proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1

   Time frame: Through study completion, up to approximately 24 months

5. Part 2: Incidence of TEAEs and SAEs

   Adverse event (AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.

   Time frame: Through study completion, an average of 24 months

Secondary outcomes

1. Part 1: Objective Response Rate (ORR) per RECIST v1.1

   Proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1

   Time frame: Through study completion, up to approximately 34 months

2. Part 1: Maximum observed plasma concentration (Cmax)

   Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

   Time frame: Through study completion, up to approximately 34 months

3. Part 1: Serum concentration at the end of the dosing interval (Ctrough)

   Ctrough is the lowest concentration of drug reached before the next dose was administered.

   Time frame: Through study completion, up to approximately 34 months

4. Part 1: Time of maximum observed serum concentration (Tmax)

   Tmax is time to reach maximum observed serum concentration obtained directly from the concentration versus time curve.

   Time frame: Through study completion, up to approximately 34 months

5. Part 1: Terminal elimination half-life (T1/2)

   Terminal half-life is the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.

   Time frame: Through study completion, up to approximately 34 months

6. Part 1: Area under the plasma concentration-time curve (AUC)

   AUC is the area under the concentration-time curve of drug

   Time frame: Through study completion, up to approximately 34 months

7. Part 1: Incidence of anti-drug antibodies (ADA)

   Number of participants with ADA positive results for BND-35

   Time frame: Through study completion, up to approximately 34 months

8. Part 2: Progression Free Survival (PFS)

   PFS is the time from the date of first dose of study drug to the date of first documented disease progression or death due to any cause, whichever occurs first.

   Time frame: Through study completion, up to approximately 24 months

9. Part 2: PFS rate

   Percentage of participants with PFS, per RECIST v1.1

   Time frame: At 3, 6, 9, and 12 months, and up to 24 months

10. Part 2: Duration of Response

    Duration between first documentation of CR or PR to first documentation of disease progression or death due to any cause, whichever occurs first

    Time frame: Through study completion, up to approximately 24 months

11. Part 2: Maximum observed plasma concentration (Cmax)

    Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

    Time frame: Through study completion, up to approximately 24 months

12. Part 2: Serum concentration at the end of the dosing interval (Ctrough)

    Ctrough is the lowest concentration of drug reached before the next dose was administered.

    Time frame: Through study completion, up to approximately 24 months

13. Part 2: Time of maximum observed serum concentration (Tmax)

    Tmax is time to reach maximum observed serum concentration obtained directly from the concentration versus time curve.

    Time frame: Through study completion, up to approximately 24 months

14. Part 2: Terminal elimination half-life (T1/2)

    Terminal half-life is the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.

    Time frame: Through study completion, up to approximately 24 months

15. Part 2: Area under the plasma concentration-time curve (AUC)

    AUC is the area under the concentration-time curve of drug

    Time frame: Through study completion, up to approximately 24 months

16. Part 2: Incidence of anti-drug antibodies (ADA)

    Number of participants with ADA positive results for BND-35

    Time frame: Through study completion, up to approximately 24 months

Individual participant data

Plan to share: No