An Open-label, Multicenter, Dose Escalation, and Dose Expansion Phase 1/2 Study With Peluntamig (PT217) Followed by a Key ChemotherapY and/or Checkpoint Inhibitor ComBination in Patients With NeuRoendocrIne Carcinomas That Are Known to be DLL3 expressinG CancErs (SKYBRIDGE)
Phanes Therapeutics
Summary
This is a first-in-human, Phase 1/2, open-label, dose escalation, dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Peluntamig (PT217) as a monotherapy and in combination with chemotherapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria 1. NECs that have transformed from NSCLC are not eligible. Part A: Patients with histologically or cytologically confirmed unresectable advanced or metastatic small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocrine carcinoma (EP-NEC). Patients with tumors that are of mixed histology are eligible only if neuroendocrine carcinoma/small cell cancer component is predominant and represents at least 50% of the overall tumor tissue. Patients with well differentiated grade 3 neuroendocrine tumors (Ki-67 ≥ 55%) may…
Interventions
- DrugPeluntamig (PT217)
A bispecific antibody (bsAb) against DLL3 and CD47.
- DrugCarboplatin + Etoposide
Administered per Standard of Care.
- DrugPaclitaxel.
Administered per Standard of Care.
- DrugAtezolizumab
Administered per Standard of Care.
Locations (12)
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, California
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Washington University School of Medicine (Siteman Cancer Center)St Louis, Missouri