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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

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

ArmDescriptionAssigned Intervention
Experimental
Cohort A (non-squamous NSCLC)
  • Drug: Zelenectide pevedotin (BT8009)
    Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Experimental
Cohort B (squamous NSCLC)
  • Drug: Zelenectide pevedotin (BT8009)
    Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

More Details

Status
Recruiting
Sponsor
BicycleTx Limited

Study Contact

BicycleTx Limited
617-945-8155
clinicalstudies@bicycletx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.