Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
NCT ID: NCT06933329
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
73 participants
INTERVENTIONAL
2025-07-18
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A (non-squamous NSCLC)
Zelenectide pevedotin (BT8009)
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Cohort B (squamous NSCLC)
Zelenectide pevedotin (BT8009)
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Interventions
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Zelenectide pevedotin (BT8009)
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Eligibility Criteria
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Inclusion Criteria
1. Cohort A: Histologically or cytologically confirmed non-squamous NSCLC.
2. Cohort B: Histologically or cytologically confirmed squamous NSCLC.
* Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay.
* Participants must not have received more than 3 prior lines of systemic therapy in the advanced/metastatic setting.
* Participants with no known actionable genomic alterations must have received both platinum based therapy and immunotherapy given either sequentially or in combination for advanced/metastatic NSCLC.
* Those with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET) are eligible provided they have received or are not candidates for available standard targeted therapy in the advanced/metastatic setting.
* Measurable disease as defined by RECIST v1.1.
* Adequate archival or fresh tumor tissue comprised of advanced or metastatic NSCLC should be available for submission to central laboratory, if not provided during prescreening.
* Life expectancy ≥ 12 weeks.
* Eastern Cooperative Oncology Group Performance Status of ≤ 1.
Exclusion Criteria
* Prior treatment with monomethyl auristatin E (MMAE) (vedotin) based therapy.
* Known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to MMAE.
* Ongoing clinically significant toxicity (Grade ≥ 2) associated with prior treatment for NSCLC (including radiotherapy or surgery), with the exception of well-controlled immuno-oncology related endocrine disorders on supportive or replacement therapy, and alopecia.
* Active keratitis or corneal ulcerations.
* Active or untreated central nervous system (CNS) metastases.
* Uncontrolled diabetes or hypertension.
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent draining procedures (monthly or more frequently).
* Active interstitial lung disease or pneumonitis requiring ongoing treatment with steroids (\>10mg/day of prednisone or equivalent) or other immunosuppressive medications; or any prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
* History or another active malignancy that would interfere with the safety or efficacy evaluation of the clinical study.
* Requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A (\[cytochrome P450 3A\] CYP3A) or inhibitors of P-glycoprotein (P-gp) including herbal- or food-based inhibitors.
* Prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment.
18 Years
ALL
No
Sponsors
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BicycleTx Limited
INDUSTRY
Responsible Party
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Locations
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Alaska Oncology and Hematology, LLC
Anchorage, Alaska, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
Clinical Research Alliance, Inc
Westbury, New York, United States
Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio, United States
Texas Oncology - Central South
Austin, Texas, United States
Texas Oncology - DFW
Dallas, Texas, United States
Virginia Cancer Specialists
Arlington, Virginia, United States
Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Hopital Foch
Suresnes, , France
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
The Royal Marsden Hospital
London, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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BT8009-202 (Duravelo-4)
Identifier Type: -
Identifier Source: org_study_id