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Study of BND-22 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04717375
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Biond Biologics

Study Description
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Brief Summary:
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 administered alone and in combination with pembrolizumab 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 and will be comprised of two parts - an initial "3 + 3" dose escalation phase followed by a dose expansion phase.

Condition or disease Intervention/treatment Phase
Cancer Drug: BND-22 Drug: Pembrolizumab Drug: Cetuximab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Dose Escalation and Expansion Study of the Safety, Tolerability, and Anti-tumor Activity of BND-22 Administered Alone and in Combination With Pembrolizumab or With Cetuximab in Patients With Advanced Solid Tumors
Actual Study Start Date : April 11, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BND-22 Dose Escalation (Sub-Part 1A)
Standard "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).
 Drug: BND-22
Monoclonal antibody administered intravenously
Experimental: BND-22 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B)
Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. BND-22 and pembrolizumab will be administered intravenously (IV), every 3 weeks (Q3W).
 Drug: BND-22
Monoclonal antibody administered intravenously

Drug: Pembrolizumab
Monoclonal antibody administered intravenously
Experimental: BND-22 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-22 and cetuximab will be administered intravenously (IV), every 2 weeks (Q2W).
 Drug: BND-22
Monoclonal antibody administered intravenously

Drug: Cetuximab
Monoclonal antibody administered intravenously
Experimental: BND-22 Dose Expansion (Part 2)
Will 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 RP2D of BND-22 has been established. BND-22 will be administered intravenously (IV), every 2 weeks (Q2W).
 Drug: BND-22
Monoclonal antibody administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Incidence of treatment-emergent adverse events (TEAEs) dose limiting toxicities (DLT) [ Time Frame: Cycle 1 (28 days) ]
    Incidence of TEAEs meeting protocol defined DLT criteria

  2. Part 1: Incidence of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 5 months ]
  3. Part 2: Objective Response Rate (ORR) per RECIST v1.1 [ Time Frame: Through study completion, an average of 3 months ]
    Proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1


Secondary Outcome Measures :
  1. Part 1: Maximum observed plasma concentration [Cmax] [ Time Frame: Through study completion, an average of 2 months ]
  2. Part 2: Maximum observed plasma concentration [Cmax] [ Time Frame: Through study completion, an average of 3 months ]
  3. Part 1: Terminal elimination half-life [T1/2] [ Time Frame: Through study completion, an average of 2 months ]
  4. Part 2: Terminal elimination half-life [T1/2] [ Time Frame: Through study completion, an average of 3 months ]
  5. Part 1: Area under the plasma concentration-time curve [AUC] [ Time Frame: Through study completion, an average of 2 months ]
  6. Part 2: Area under the plasma concentration-time curve [AUC] [ Time Frame: Through study completion, an average of 3 months ]
  7. Part 1: Incidence of anti-drug antibodies (ADA) [ Time Frame: Through study completion, an average of 5 months ]
  8. Part 2: Incidence of anti-drug antibodies (ADA) [ Time Frame: Through study completion, an average of 6 months ]
  9. Part 2: Progression Free Survival [ Time Frame: Through study completion, an average of 3 months ]
    Time from the date of first dose of study drug to the date of first documented disease progression or death

  10. Part 2: Duration of Response [ Time Frame: Through study completion, an average of 6 months ]
    Duration between first documentation of CR or PR to first documentation of disease progression or death

  11. Part 2: Incidence of Serious Adverse Events and Adverse Events [ Time Frame: Through study completion, an average of 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • History of life-threatening toxicity related to prior cetuximab or other anti-EGFR antibodies (for Sub-Part 1C)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717375


Contacts
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Contact: Itay Friedman, MD +972-48844337 itay@biondbio.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Mitesh Borad, MD    480-342-4800      
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Marwan Fakih, MD    626-256-4673 ext 83087    mfakih@coh.org   
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Christopher Lieu, MD    720-848-3532    CHRISTOPHER.LIEU@CUANSCHUTZ.EDU   
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
Contact: Ingrid Palma    203-200-2486    Ingrid.palma@yale.edu   
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Zhaohui Jin, MD    507-284-2511      
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Contact: Liat Rapaport    972-4-777-6731    L_Rapaport@rambam.health.gov.il   
Hadassah University Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Cecilia Lellouche    972-2-6779129    CECILIAL@hadassah.org.il   
Rabin Medical Center Recruiting
Petah Tikva, Israel, 49100
Contact: Gal Medalia    972-3-937-8023    Galmed@clalit.org.il   
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Ilanit Redinsky    972-3-530-4498    Ilanit.Redinsky@sheba.health.gov.il   
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 6423906
Contact: Limor Ben Zvi    972-3-697-3193    limorb@tlvmc.gov.il   
Sponsors and Collaborators
Biond Biologics
Investigators
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Study Director: Itay Friedman, MD Biond Biologics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biond Biologics
ClinicalTrials.gov Identifier: NCT04717375    
Other Study ID Numbers: BND-22-001
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pembrolizumab
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents