AzTrials
AzTrials

Small Cell Lung Cancer (SCLC)Phase 1/2NCT05652686

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

A Phase 1/2 study testing Peluntamig (PT217), Carboplatin + Etoposide and Paclitaxel. in people with Small Cell Lung Cancer (SCLC) and Large Cell Neuroendocrine Cancer (LCNEC), run by Phanes Therapeutics at 15 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Peluntamig (PT217), Carboplatin + Etoposide and Paclitaxel.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
15 sitesUnited States
Study dates
5 Sep 2023to Aug 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older and able to sign informed consent and comply with the protocol.
  • Measurable disease as defined by RECIST v1.1 criteria for solid tumors.
  • 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.
Show all 18Show fewer
  • 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.
  • 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.

Who cannot join

  • 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.
  • Additional inclusion and exclusions criteria will apply.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Phanes Therapeutics contact

858-766-0852

clinical-trials@phanestx.com

15 sites in 1 country

United States15 sites, 15 recruiting

  • Sidney Kimmel Comprehensive Cancer Center at John Hopkins

    Baltimore, Maryland, 21287

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

    Recruiting

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Recruiting

  • Yale University Cancer Center

    New Haven, Connecticut, 06520

    Recruiting

  • Sarah Cannon Research Institute University of Oklahoma

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Recruiting

  • Mays Cancer Center / University of Texas, San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • Fred Hutch Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Washington University School of Medicine (Siteman Cancer Center)

    St Louis, Missouri, 63108

    Recruiting

Other trials in United States

About this study

Official title: 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)

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.

Being tested
Peluntamig (PT217), Carboplatin + Etoposide, Paclitaxel., Atezolizumab, Lurbinectedin
Keywords
DLL3, DLL3 expressing tumors, Lung cancer, SCLC, LCNEC, NEPC, GEP-NEC, Small Cell Lung Cancer, Large cell neuroendocrine cancer, Neuroendocrine prostate cancer, Gastroenteropancreatic neuroendocrine carcinoma, Neuroendocrine carcinoma, Extrapulmonary neuroendocrine carcinoma, EP-NEC, CD47
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peluntamig (PT217)Drug

    A bispecific antibody (bsAb) against DLL3 and CD47.

  • Carboplatin + EtoposideDrug

    Administered per Standard of Care.

  • Paclitaxel.Drug

    Administered per Standard of Care.

  • AtezolizumabDrug

    Administered per Standard of Care.

  • LurbinectedinDrug

    Administered per Standard of Care.

  • Irinotecan (drug)Drug

    Administered per Standard of Care.

  • TopotecanDrug

    Administered per Standard of Care.

Study groups in NCT05652686
Study groupRoleWhat they receive
Part A: Dose EscalationExperimentalA standard 3+3 dose escalation design will be employed.
Receives: Drug: Peluntamig (PT217)
Part B: Dose ExpansionExperimentalPart B cohorts will open after the dose level considered for RDE has been cleared in Parts A, C and D.
Receives: Drug: Peluntamig (PT217)
Part C: Chemotherapy Combination TherapyExperimentalPart C of the study will include substudies C1 to C5, combining Peluntamig (PT217) with chemotherapy.
Receives: Drug: Peluntamig (PT217); Drug: Carboplatin + Etoposide; Drug: Paclitaxel.; Drug: Lurbinectedin; Drug: Irinotecan (drug); Drug: Topotecan
Part D: ICI Combination TherapyExperimentalIn part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy.
Receives: Drug: Peluntamig (PT217); Drug: Carboplatin + Etoposide; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine recommended dose for expansion (RDE) of Peluntamig (PT217).

    Measured: Through study completion, up to approximately 3 years.

  2. To evaluate the safety and tolerability of Peluntamig (PT217).

    Measured: Through study completion, up to approximately 3 years.

  3. To evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments as assessed by ORR.

    Measured: Through study completion, up to approximately 3 years.

Secondary outcomes (3)

  1. To evaluate the pharmacokinetics of Peluntamig (PT217).

    Measured: Through study completion, up to approximately 3 years.

  2. To evaluate the immunogenicity (ADA) of Peluntamig (PT217).

    Measured: Through study completion, up to approximately 3 years.

  3. To further evaluate the efficacy of Peluntamig (PT217) monotherapy or in combination treatments

    Measured: Through study completion, up to approximately 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2022
  2. Study start5 Sep 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The study will consist of 4 parts: Dose Escalation (Part A), Dose Expansion (Part B), Chemo Combination Therapy (Part C) and ICI combination Therapy (Part D).
Masking
None (open label)
Enrolment
203 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05652686
Sponsor's protocol ID
PT217X1101
Status last verified
Jul 2026
First submitted
7 Dec 2022
Last updated
15 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Peluntamig (PT217), Carboplatin + Etoposide and Paclitaxel. in people with Small Cell Lung Cancer (SCLC) and Large Cell Neuroendocrine Cancer (LCNEC), run by Phanes Therapeutics at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Phanes Therapeutics (858-766-0852, clinical-trials@phanestx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine recommended dose for expansion (RDE) of Peluntamig (PT217). (time frame: Through study completion, up to approximately 3 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05652686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in