Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
Purpose
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).
Condition
- Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort A (non-squamous NSCLC) |
|
|
|
Experimental Cohort B (squamous NSCLC) |
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Recruiting Locations
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- BicycleTx Limited