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

Detailed criteria

Key Inclusion Criteria 1. 18 years or older and able to sign informed consent and comply with the protocol. 2. Measurable disease as defined by RECIST v1.1 criteria for solid tumors. 3. 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…

Interventions

Drug
Peluntamig (PT217)
A bispecific antibody (bsAb) against DLL3 and CD47.
Drug
Carboplatin + Etoposide
Administered per Standard of Care.
Drug
Paclitaxel.
Administered per Standard of Care.
Drug
Atezolizumab
Administered per Standard of Care.
Drug
Lurbinectedin
Administered per Standard of Care.
Drug
Irinotecan (drug)
Administered per Standard of Care.
Drug
Topotecan
Administered per Standard of Care.

Locations (15)

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California
USC Norris Comprehensive Cancer Center
Los Angeles, California
Sarah Cannon Research Institute at HealthONE
Denver, Colorado
Yale University Cancer Center
New Haven, Connecticut
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland
Massachusetts General Hospital
Boston, Massachusetts