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

BicycleTx

Status and phase

Enrolling

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Zelenectide pevedotin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06933329

BT8009-202 (Duravelo-4)

Details and patient eligibility

About

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 prior line of systemic 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).

Enrollment

73 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 have received at least 1 prior line 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. Must not have received more than 3 prior lines of systemic therapy in the advanced/metastatic setting.
- Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) 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. (Note: Immunosuppressive therapies should be stopped or tapered down to ≤10 mg/day prednisone or equivalent before first study drug administration.)
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 of another active malignancy, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other malignancies curatively treated with no evidence of disease for ≥3 years.
Known requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A ([cytochrome P450 3A] CYP3A) including herbal- or food-based inhibitors/inducers.
Prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment.