Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

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 non-small cell lung cancer (NSCLC) who have received at least one line of therapy in the advanced/metastatic setting (see inclusion criteria below). The study will comprise of 2 cohorts: Cohort A (non-squamous NSCLC) and Cohort B (squamous NSCLC).

Eligibility

Key Inclusion Criteria

* Histologically or cytologically confirmed advanced or metastatic NSCLC.

  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.

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

Conditions3

Locations10 sites

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