Trials / Recruiting
RecruitingNCT05652686
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
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)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 203 (estimated)
- Sponsor
- Phanes Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Peluntamig (PT217) | A bispecific antibody (bsAb) against DLL3 and CD47. |
| DRUG | Carboplatin + Etoposide | Administered per Standard of Care. |
| DRUG | Paclitaxel. | Administered per Standard of Care. |
| DRUG | Atezolizumab | Administered per Standard of Care. |
Timeline
- Start date
- 2023-09-05
- Primary completion
- 2027-12-01
- Completion
- 2028-08-01
- First posted
- 2022-12-15
- Last updated
- 2025-09-23
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05652686. Inclusion in this directory is not an endorsement.