Status:
RECRUITING
Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
BicycleTx Limited
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated NECTIN4-amplified advanced or metastatic no...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Histologically or cytologically confirmed advanced or metastatic NSCLC.
- Cohort A: Histologically or cytologically confirmed non-squamous NSCLC.
- 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.
- Key Exclusion Criteria
- Evidence of mixed small cell lung cancer (SCLC) and NSCLC histology.
- 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.
- Note: Additional protocol defined Inclusion/Exclusion criteria apply
Exclusion
Key Trial Info
Start Date :
July 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06933329
Start Date
July 18 2025
End Date
February 28 2029
Last Update
December 17 2025
Active Locations (18)
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1
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, United States, 99508
2
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
Clinical Research Alliance, Inc
Westbury, New York, United States, 11590
4
Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio, United States, 45014