A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKY… (NCT05652686) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
United States203 participantsStarted 2023-09-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 be considered if their tumors are DLL3 positive.
✓. Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably a newly acquired biopsy, or if not possible, archival tissue) to be assessed for DLL3 expression and other biomarkers.
✓. ECOG performance status of 0 or 1.
✓. Adequate organ function confirmed at screening and within 72 hours of initiating C1D1 of Peluntamig (PT217) treatment.
Exclusion criteria
✕. Women who are pregnant or lactating.
✕. Women of child-bearing potential (WOCBP) who do not use adequate birth control.
✕. Autoimmune disease requiring systemic treatment within the past twelve months.
✕. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2, and excluding ICIs) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment with Peluntamig (PT217).
✕. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications (≥ 10 mg prednisone, or equivalent) within 14 days prior to study drug Peluntamig (PT217), or anticipation of need for systemic immunosuppressive medication during study drug Peluntamig (PT217).
What they're measuring
1
To determine the dose-limiting toxicity (DLT) of Peluntamig (PT217).
Timeframe: Through study completion.
2
To determine the maximum tolerated dose (MTD) of Peluntamig (PT217) if reached.
Timeframe: Through study completion.
3
To determine recommended dose for expansion (RDE) of Peluntamig (PT217).
Timeframe: Through study completion.
4
To evaluate the safety and tolerability of Peluntamig (PT217).
Timeframe: Through study completion.
5
To evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments