Clinical Trials /

Study of BND-22 in Participants With Advanced Solid Tumors

NCT04717375

Description:

This is an open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of BND-22. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase followed by a dose expansion phase.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Breast Carcinoma
  • Cervical Carcinoma
  • Cholangiocarcinoma
  • Esophageal Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma
  • Gallbladder Carcinoma
  • Gastric Adenocarcinoma
  • Gastric Squamous Cell Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Renal Cell Carcinoma
  • Skin Squamous Cell Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of BND-22 in Participants With Advanced Solid Tumors
  • Official Title: A Phase 1/2, Dose Escalation and Expansion Study of the Safety, Tolerability, and Anti-tumor Activity of BND-22 in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: BND-22-001
  • NCT ID: NCT04717375

Conditions

  • Cancer

Interventions

DrugSynonymsArms
BND-22BND-22 Dose Escalation

Purpose

This is an open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of BND-22. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase followed by a dose expansion phase.

Trial Arms

NameTypeDescriptionInterventions
BND-22 Dose EscalationExperimentalStandard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. BND-22 will be administered intravenously (IV), every 2 weeks (Q2W).
  • BND-22
BND-22 Dose ExpansionExperimentalWill include three expansion cohorts enrolling patients with advanced stage squamous cell carcinoma of the head and neck, gastric or gastroesophageal junction adenocarcinoma, and non-small cell lung cancer. Enrollment will start after the recommended phase 2 dose (RP2D) of BND-22 has been established. BND-22 will be administered intravenously (IV), every 2 weeks (Q2W).
  • BND-22

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with unresectable or metastatic disease who are refractory to or are not
             candidates for standard approved therapy

          -  Histologic confirmation of malignancy

          -  Measurable disease per RECIST v1.1

          -  Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1

          -  Participants must have adequate organ function as defined by lab tests

          -  Part 1: Following tumor types: Breast cancer, cervical cancer, colorectal cancer,
             adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or
             gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and
             neck, hepatobiliary cancers (hepatocellular carcinoma (HCC), gallbladder cancer,
             cholangiocarcinoma), non-small cell lung cancer, renal cell carcinoma, squamous cell
             carcinoma of the skin, or urothelial carcinoma

          -  Part 2: Following tumor types: Squamous cell carcinoma of the head and neck, Gastric
             or gastroesophageal junction adenocarcinoma, Non-small cell lung cancer

        Exclusion Criteria:

          -  Active, known or suspected autoimmune disease

          -  Condition requiring systemic treatment with either corticosteroids or other
             immunosuppressive medications

          -  Brain or leptomeningeal metastases

          -  Known history of positive test for HIV

          -  Non-HCC patients: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV);
             HCC patients: untreated active HBV or dual infection with HBV/HCV

          -  Participants after solid organ or allogeneic hematopoietic stem cell transplant

          -  History of life-threatening toxicity related to prior immune therapy

          -  Unstable or deteriorating cardiovascular disease within the previous 6 months

          -  Any major surgery within 4 weeks of study drug administration

          -  Prior/Concomitant Therapy:

          -  Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from
             last dose

          -  Use of other investigational drugs within 28 days

          -  Prior treatment with macrophage or natural killer (NK) cells activating therapies

          -  Administration of a live attenuated vaccine within 28 days
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1: Incidence of treatment-emergent adverse events (TEAEs) dose limiting toxicities (DLT)
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:Incidence of TEAEs meeting protocol defined DLT criteria

Secondary Outcome Measures

Measure:Part 1: Maximum observed plasma concentration [Cmax]
Time Frame:Through study completion, an average of 2 months
Safety Issue:
Description:
Measure:Part 2: Maximum observed plasma concentration [Cmax]
Time Frame:Through study completion, an average of 3 months
Safety Issue:
Description:
Measure:Part 1: Terminal elimination half-life [T1/2]
Time Frame:Through study completion, an average of 2 months
Safety Issue:
Description:
Measure:Part 2: Terminal elimination half-life [T1/2]
Time Frame:Through study completion, an average of 3 months
Safety Issue:
Description:
Measure:Part 1: Area under the plasma concentration-time curve [AUC]
Time Frame:Through study completion, an average of 2 months
Safety Issue:
Description:
Measure:Part 2: Area under the plasma concentration-time curve [AUC]
Time Frame:Through study completion, an average of 3 months
Safety Issue:
Description:
Measure:Part 1: Incidence of anti-drug antibodies (ADA)
Time Frame:Through study completion, an average of 5 months
Safety Issue:
Description:
Measure:Part 2: Incidence of anti-drug antibodies (ADA)
Time Frame:Through study completion, an average of 6 months
Safety Issue:
Description:
Measure:Part 2: Progression Free Survival
Time Frame:Through study completion, an average of 3 months
Safety Issue:
Description:Time from the date of first dose of study drug to the date of first documented disease progression or death
Measure:Part 2: Duration of Response
Time Frame:Through study completion, an average of 6 months
Safety Issue:
Description:Duration between first documentation of CR or PR to first documentation of disease progression or death
Measure:Part 2: Incidence of Serious Adverse Events and Adverse Events
Time Frame:Through study completion, an average of 6 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Biond Biologics

Last Updated

January 26, 2021