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NCT Number: NCT07797907

This Clinical Study is to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of BD200 in Participants With Advanced or Metastatic Cancer.

The Phase 1 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of BD200 in adult participants with advanced solid cancers. This is an open-label study consisting of two-parts: Part A Dose Escalation and Part B Dose Expansion. At least one tumor-specific cohort will be selected in Part B Dose Expansion.

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Key information

Conditions

Solid Tumor (Phase I)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18+ years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Participant willing to provide tumor biopsies
  • Measurable disease per RECIST v1.1
  • Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options
  • Satisfy requirements for prior treatments per tumor type as outlined in the protocol
  • Adequate organ function
  • Agree to contraception requirements as outlined in the protocol

Exclusion criteria

  • Any major surgery or traumatic injury prior to enrollment
  • Unhealed wounds from surgery or injury
  • Received other therapies within 4 weeks prior to enrollment
  • Any clinically significant chronic gastrointestinal (GI) disorder
  • Any clinically significant ascites or liver disease
  • Any clinically significant pulmonary compromise
  • Active infection at the time enrollment
  • Active autoimmune disease
  • History or active skin disease requiring frequent treatment
  • Any clinically significant corneal disorder
  • Active known second malignancy
  • Any clinically significant cardiac disease
  • Participants with tumor abutting or eroding a major vessel
  • Pregnant or lactating or planning to become pregnant
  • Known hypersensitivity to BD200 or any of its ingredients
  • Unresolved toxicities from previous anticancer therapy
  • Participation in a concurrent clinical study in the treatment period
  • Part A Only: Participant with hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV) infection

Note: Other inclusion and exclusion criteria may apply.

Treatment and study plan

BD200

Drug

Infusion

Primary outcomes

  1. Phase 1 Part A

    Time frame: Cycle 1 Day 1 through Cycle 1 Day 21 [approximately 21 days]

    Number of Participants with Dose Limiting Toxicities (DLTs)

  2. Phase 1 Part A & Part B

    Time frame: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [approximately 12 months]

    Number of Participants with Treatment-emergent Adverse Events (TEAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation

  3. Phase 1 Part A & Part B

    Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])

    Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator

  4. Phase 1 Part A & Part B

    Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]

    Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator

Secondary outcomes

  1. Phase 1 Part A & Part B

    Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])

    Area Under the Concentration Time Curve (AUC) of BD200

  2. Phase 1 Part A & Part B

    Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])

    Maximum Observed Plasma Concentration (Cmax) of BD200

  3. Phase 1 Part A & Part B

    Time frame: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]

    Number of Participants with Anti-drug Antibodies (ADAs) in Blood

  4. Phase 1 Part A

    Time frame: Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]

    ORR per RECIST Version 1.1 as Assessed by Investigator

  5. Phase 1 Part A

    Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])

    DOR per RECIST Version 1.1 as Assessed by Investigator

  6. Phase 1 Part B

    Time frame: Cycle 1 Day 1 through EOT [up to approximately 12 months]

    IHC biopsy data of Trop-2 and Nectin 4 Expression

  7. Phase 1 Part B

    Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])

    Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator

  8. Phase 1 Part B

    Time frame: Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months])

    Overall Survival (OS)

Study contacts

Contact information is provided by the study sponsor or research team.

Biolojic Design, Ltd.

CONTACT

[email protected]

+972-8-6988048

Sponsors and collaborators

Lead sponsor

Biolojic Design Ltd.

Industry

Registry information

Official study title

A Phase 1a/b, First-in-Human Dose Escalation and Dose Expansion Clinical Study of the Dual Targeting Trop-2 and Nectin-4 Multibody Drug Conjugate BD200 in Participants With Select Unresectable Locally Advanced or Metastatic Cancers

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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