Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies

Study Identifier:
BT7480-100
CT.gov Identifier:
NCT05163041
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

To evaluate the safety and tolerability of BT7480, and to determine a recommended Phase II dose (RP2D)

To assess the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies

To investigate safety and efficacy in indications with evidence of Nectin-4 expression.

To determine a recommended Phase 2 dose to further explore efficacy and safety.

Pharmacokinetic and pharmacodynamic analyses will be performed to support dose escalation decisions and increase the understanding of safety and clinical activity signals observed during the study. Tumor response will be assessed per RECIST every 8 weeks.

The main goals of the study are to:

Find the recommended dose of BT7480 that can be given safely to participants alone and in combination with nivolumab

Learn about the side effects and effectiveness of BT7480 alone and in combination with nivolumab

Learn about the effect BT7480 has on the body and how BT7480 is cleared by the body

Learn about the side effects and effectiveness of BT7480 in patients with reduced kidney functio

To assess safety, clinical activity, and pharmacokinetics (PK) and pharmacodynamics (PD) of BT7480.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Arms:
    • Read More
  • Drug: Experimental: BT7480 and nivolumab dose escalation
  • Drug: Experimental: BT7480 monotherapy dose expansion
  • Drug: Experimental: BT7480 and nivolumab dose expansion
  • Drug: Experimental: BT7480 monotherapy in patients with renal insufficiency
  • Drug: BT7480 administered as an intravenous infusion QW in a 28-day cycle
  • Drug: AACR 2023:
  • Drug: ESMO 2024:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Must have locally advanced or metastatic disease that is refractory to standard therapy, or for which no standard therapy is judged to be appropriate or provide clinical benefit, as judged by the Investigator
    • Must have a histologically or cytologically confirmed malignant solid tumor associated with Nectin-4 expression, including, but not limited to, urothelial (transitional cell) carcinoma; head and neck squamous cell carcinoma; non-small cell lung cancer; and ovarian, breast, gastric, or esophageal carcinoma
    • Must have ECOG performance status score 0 or 1 and acceptable organ and hematological function
    • Must have metastatic or locally advanced disease and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    • Life expectancy ≥12 weeks
    • Must submit fresh or archival tumor tissue
    • Must provide written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analysis
    • Additional key criteria include ≥18 years of age, ECOG of 0 or 1, adequate organ function, and no prior therapy with a CD137-targeted agent.
    Exclusion criteria
    • Prior therapy with a cytotoxic, small molecule, or other systemic chemotherapy within 14 days of the first dose of study drug
    • Prior immunotherapy, including monoclonal antibodies, within 28 days or 5 half-lives of the first dose of study drug, whichever is shorter
    • Prior treatment with CD137 targeted therapy
    • Body mass index greater than or equal to 35 kg/m^2
    • Mean resting QTc (eg, QTcF) greater than 470 msec on triplicate electrocardiograms (ECGs) obtained at screening
    • Uncontrolled symptomatic brain metastases
    • Uncontrolled diabetes with glycosylated hemoglobin greater than or equal to 8%
    • Uncontrolled hypertension at screening or prior to initiation of study drug
    • History of autoimmune disease except well-controlled diabetes mellitus, alopecia, well controlled thyroid disease or vitiligo
    • Patients must have an advanced malignancy associated with Nectin-4 expression that is not eligible for standard therapy
    • Exclusion criteria include uncontrolled brain metastases, uncontrolled hypertension, significant history of autoimmune disease and prior CD137 targeted therapy.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor