Testing Peluntamig for Neuroendocrine Carcinomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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 eligibility criteria as patients in Part A, C or D.

   Part C:
   * 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.

   Part D:
   * 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.

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.

Additional inclusion and exclusions criteria will apply.

Where it's running

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

Study contacts

• Study coordinator: Phanes Therapeutics
• Email: clinical-trials@phanestx.com
• Phone: 858-766-0852

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• First-in-human ML261 CAR T therapy for relapsed/refractory SCLC and select neuroendocrine cancers

  This early-phase study tests whether a patient’s own ML261 CAR T cells can be safely given to see if they help people with relapsed or refractory SCLC or certain neuroendocrine cancers.

  Recruiting at 7 sites Phase 1 Moonlight Bio, Inc · St Louis, Missouri and 6 other locations · NCT07488923

• Multiomic analysis in relapsed small-cell lung cancer with DLL3 T cell engager

  This observational study tests how blood and tumor markers change over time in adults with relapsed small-cell lung cancer who are receiving a DLL3-targeted therapy, to see if those changes relate to clinical outcomes.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07795411

• DLL3-targeted alpha radiotherapy ([212Pb]Pb-MP0712) for advanced small cell lung cancer and DLL3-positive neuroendocrine tumors

  This will test a DLL3-targeted radioactive drug ([212Pb]Pb-MP0712) to see if it's safe and can shrink tumors in adults with advanced small cell lung cancer or other DLL3-positive neuroendocrine cancers.

  Recruiting at 8 sites Phase 1/2 Molecular Partners AG · Tampa, Florida and 7 other locations · NCT07278479

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• Exploration of whole-brain radiotherapy with PD-1 inhibitors for brain injury in SCLC

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• Propranolol with Adebrelimab and Platinum Chemotherapy in Small Cell Lung Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.