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

Last updated: August 6, 2024
Sponsor: Biond Biologics
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer

Treatment

BND-35

Cetuximab

Nivolumab

Clinical Study ID

NCT06274437
BND-35-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with unresectable or metastatic disease who are refractory to or are notcandidates 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 laboratory tests

  • Part 1: Following tumor types: Breast cancer, cholangiocarcinoma, colorectal cancer,adenocarcinoma or squamous cell carcinoma of the esophagus, gastric orgastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head andneck, non-small cell lung cancer, melanoma, ovarian cancer, renal cell carcinoma,pancreatic adenocarcinoma, soft tissue sarcomas

Exclusion

Exclusion Criteria:

  • Active, known or suspected autoimmune disease

  • Condition requiring systemic treatment with either corticosteroids or otherimmunosuppressive medications

  • Brain or leptomeningeal metastases

  • Known history of positive test for HIV or known AIDS

  • Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (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 otheranti-epidermal growth factor receptor 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 immune therapy treatments, unless at least 4 weeks have elapsed from last dose

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

  • Use of other investigational drugs within 28 days

  • Prior treatment with immunoglobulin-like transcripts (ILT3)-targeting agents

  • Administration of a live attenuated vaccine within 28 days

Study Design

Total Participants: 280
Treatment Group(s): 3
Primary Treatment: BND-35
Phase: 1
Study Start date:
June 02, 2024
Estimated Completion Date:
November 30, 2027

Study Description

Estimated Study Duration:

Dose Escalation (Part 1): Approximately 34 months. Dose Optimization/Expansion (Part 2): Approximately 24 months.

Connect with a study center

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Hadassah University Medical Center

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 49100
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

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