An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of BND-22 in Patients with Advanced Solid Tumors

Overview

About this study

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of BND-22 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 with subparts 1A (monotherapy BND-22), 1B (BND-22 in combination with pembrolizumab) and 1C (BND-22 in combination with cetuximab) followed by a dose expansion phase (part 2) 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.
  • 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.

Eligibility last updated 11/1/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Zhaohui Jin, M.D.

Contact us for the latest status

Contact information:

Chelsie Dinges

(507) 422-5403

Dinges.Chelsie@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Open for enrollment

Contact information:

Sarah Hernandez

(480) 342-6046

Hernandez.Sarah1@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20512980

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