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The SKYBRIDGE Study: Peluntamig (PT217) for Neuroendocrine Cancers

This study, called SKYBRIDGE, is testing a new drug called Peluntamig (PT217) for people with certain types of neuroendocrine cancers, including small cell lung cancer (SCLC) and large cell neuroendocrine cancer (LCNEC). Peluntamig is a bispecific antibody (a type of targeted therapy) that works by blocking two specific proteins, DLL3 and CD47. Researchers want to find the best dose of Peluntamig, see how safe it is, and if it helps shrink tumors when given alone or with standard chemotherapy drugs like Carboplatin + Etoposide, Paclitaxel, Atezolizumab, or Lurbinectedin. You might be eligible if you are 18 or older, have measurable cancer, and your cancer is not a neuroendocrine cancer that started as non-small cell lung cancer. The study is currently recruiting about 203 participants.

Study design
This is a Phase 1/2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves increasing doses to find the best one, then expanding to more participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for safety and effectiveness through study completion, which is expected to be up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05652686

A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Phanes Therapeutics
~203 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Peluntamig (PT217)Carboplatin + EtoposidePaclitaxel.AtezolizumabLurbinectedinIrinotecan (drug)

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine recommended dose for expansion (RDE) of Peluntamig (PT217).
Measured over Through study completion, up to approximately 3 years.
+2 more outcomes measured

Conditions

Small Cell Lung Cancer (SCLC)
Large Cell Neuroendocrine Cancer (LCNEC)
Neuroendocrine Prostate Cancer (NEPC)
Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)
Neuroendocrine Carcinomas (NEC)
Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)

Explore related trials

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Where it's being run

15 sites across 12 states
California2
Massachusetts2
North Carolina2
Colorado1
Connecticut1
Maryland1
Missouri1
Oklahoma1

Who to contact

Phanes Therapeutics
[email protected]
858-766-0852
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Substudy C1: patients with LCNEC or EP-NEC eligible for first-line (1L) CE treatment. SCLC patients who have relapsed on a 1L treatment (including platinum-based therapy with or without ICI) but remain platinum sensitive (defined as patients who experienced disease progression at least 90 days after their last platinum based chemotherapy) and are eligible for CE treatment rechallenge.
Substudy C2: patients with SCLC, LCNEC and EP-NEC eligible for second line (2L) paclitaxel treatment.
Substudies C3 and C5: patients with SCLC eligible for 2L or 3L treatment with lurbinectedin (C3) or topotecan (C5) are eligible. Patients with SCLC who progressed on or were intolerant of DLL3-targeting therapies (including but not limited to tarlatamab) can be enrolled into substudies C3 or C5 for 3L treatment.
Substudy C4: patients with SCLC, LCNEC or EP-NEC eligible for 2L irinotecan, or patients with SCLC eligible for 3L irinotecan. Patients with SCLC who progressed on or were intolerant of DLL3-targeting therapies (including but not limited to tarlatamab) can be enrolled into substudy C4 for 3L treatment.
Substudy D1: will include 2L patients with SCLC, LCNEC, pr EP-NEC (excluding GEP-NEC) that have progressed/relapsed from their first-line treatment that may have included an ICI.
Substudy D2: will include 1L ES-SCLC patients that have completed their induction therapy with carboplatin and etoposide plus atezolizumab and are eligible to continue with atezolizumab. These patients must have either stable disease or partial response prior to enrollment.
Substudy D3: will include 1L ES-SCLC patients that are treatment naïve or have received C1D1/2/3 and are eligible for treatment with CE plus atezolizumab. 4. 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. 5. ECOG performance status of 0 or 1. 6. Adequate organ function confirmed at screening and within 72 hours of initiating C1D1 of Peluntamig (PT217) treatment.

What this trial measures

  • To determine recommended dose for expansion (RDE) of Peluntamig (PT217).Through study completion, up to approximately 3 years.
  • To evaluate the safety and tolerability of Peluntamig (PT217).Through study completion, up to approximately 3 years.
  • To evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments as assessed by ORR.Through study completion, up to approximately 3 years.