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Testing Peluntamig for Neuroendocrine Carcinomas

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)

Phase1; Phase2 Interventional Phanes Therapeutics · NCT05652686

This study is testing a new drug called Peluntamig to see if it can safely help people with different types of neuroendocrine cancers, either on its own or with chemotherapy.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment203 (estimated)
Ages18 Years and up
SexAll
SponsorPhanes Therapeutics Industry-sponsored
Drugs / interventionsatezolizumab, chemotherapy, prednisone
Locations12 sites (Duarte, California and 11 other locations)
Trial IDNCT05652686 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of Peluntamig (PT217) in patients with various neuroendocrine carcinomas, including small cell lung cancer and large cell neuroendocrine cancer. It is a first-in-human, Phase 1/2 study that involves dose escalation and expansion, assessing Peluntamig both as a standalone treatment and in combination with chemotherapy agents like Carboplatin and Etoposide. The trial aims to gather data on the drug's pharmacokinetics and pharmacodynamics, as well as its preliminary efficacy in treating these aggressive cancers.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable advanced or metastatic neuroendocrine carcinomas expressing DLL3, who have either progressed after standard treatments or for whom such treatments are not available.

Not a fit: Patients with neuroendocrine carcinomas that have transformed from non-small cell lung cancer are not eligible and may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat neuroendocrine carcinomas.

How similar studies have performed: Other studies targeting DLL3 expressing tumors have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 be considered if their tumors are DLL3 positive.

   Patients may have progressed after standard of care treatments (at least one line of platinum-based chemotherapy with or without immune checkpoint inhibitor for SCLC patients) or other treatment options, or for whom treatment is not available or not tolerated.

   Part B: Patients must meet the same criteria in Part A, C or D.

   Part C:

   • Cohort 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.

   Cohort C2: patients with SCLC, LCNEC and EP-NEC eligible for second line (2L) paclitaxel treatment.

   Part D:
   * Cohort D1: will include 2L patients with SCLC, LCNEC, pr EP-NEC that have progressed/relapsed from their first-line treatment that may have included an ICI.
   * Cohort 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.
   * Cohort 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.
2. 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.
3. ECOG performance status of 0 or 1.
4. Adequate organ function confirmed at screening and within 72 hours of initiating C1D1 of Peluntamig (PT217) treatment.

Key Exclusion Criteria

1. Women who are pregnant or lactating.
2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.
3. Autoimmune disease requiring systemic treatment within the past twelve months.
4. 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).
5. 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).
6. Patients who have experienced Grade ≥ 3 immune-related events, such as (non-infectious) pneumonitis, interstitial lung disease, myocarditis.
7. Treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of study treatment with Peluntamig (PT217).
8. Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed.

   Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 14 days are eligible for treatment.
9. Impaired cardiac function or significant diseases.
10. For Part D only, uncontrolled hypercalcemia.
11. For Part D only, significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
12. Prior hemolytic anemia or Evans Syndrome in the last 3 months.
13. Patients who have Grade ≥ 3 neuropathy.
14. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants .

Additional criteria may apply.

Where this trial is running

Duarte, California and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Small Cell Lung CancerLarge Cell Neuroendocrine CancerNeuroendocrine Prostate CancerGastroenteropancreatic Neuroendocrine CarcinomaNeuroendocrine CarcinomasExtrapulmonary Neuroendocrine CarcinomaDLL3DLL3 expressing tumors
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.