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

Part of paid clinical trials in Duarte, California.

Sponsor
Phanes Therapeutics
Study ID
NCT05652686
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Peluntamig (PT217) — DRUG
    A bispecific antibody (bsAb) against DLL3 and CD47.
  • Carboplatin + Etoposide — DRUG
    Administered per Standard of Care.
  • Paclitaxel. — DRUG
    Administered per Standard of Care.
  • Atezolizumab — DRUG
    Administered per Standard of Care.
  • Lurbinectedin — DRUG
    Administered per Standard of Care.
  • Irinotecan (drug) — DRUG
    Administered per Standard of Care.
  • Topotecan — DRUG
    Administered per Standard of Care.

Study Details

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.

Key Dates

First listed
Dec 15, 2022
Start date
Sep 5, 2023
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
203 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Dose Escalation
    A standard 3+3 dose escalation design will be employed.
  • Experimental: Part B: Dose Expansion
    Part B cohorts will open after the dose level considered for RDE has been cleared in Parts A, C and D.
  • Experimental: Part C: Chemotherapy Combination Therapy
    Part C of the study will include substudies C1 to C5, combining Peluntamig (PT217) with chemotherapy.
  • Experimental: Part D: ICI Combination Therapy
    In part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy.

Primary Outcome Measure

To determine recommended dose for expansion (RDE) of Peluntamig (PT217). [ Time Frame: Through study completion, up to approximately 3 years. ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Yale University Cancer CenterNew HavenConnecticut06520-
Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of Medicine (Siteman Cancer Center)St LouisMissouri63108-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Sarah Cannon Research Institute University of OklahomaOklahoma CityOklahoma73104-
Providence Portland Medical CenterPortlandOregon97213-
Mays Cancer Center / University of Texas, San AntonioSan AntonioTexas78229-
NEXT VirginiaFairfaxVirginia22031-
Fred Hutch Cancer CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CASarah Cannon Research Institute at HealthONE· Denver, COYale University Cancer Center· New Haven, CTSidney Kimmel Comprehensive Cancer Center at John Hopkins· Baltimore, MDDana-Farber Cancer Institute· Boston, MA

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