Skybridge (Neuroendocrine Carcinoma) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called PT217 (the study drug) is a safe and effective option for people who have neuroendocrine carcinomas. We want to see how this drug works when it is given on its own and in combination with standard chemotherapy and/or immunotherapy drugs.
What is the Condition Being Studied?
NeuroendocrIne Carcinomas That Express DLL3 (Delta-Like Ligand 3)
Who Can Participate in the Study?
Adults ages 18+ who:
- Have one of the following types of cancer: small cell lung cancer (SCLC), large cell neuroendocrine carcinoma (LCNEC), or extrapulmonary neuroendocrine carcinoma (EP-NEC)
- Have disease that is advanced (metastatic or unresectable), relapsed, first-line, or second-line
For more information, contact the study team at ryan.woelfel@duke.edu.
Grupo etario
Adultos
What is Involved?
This study has 3 phases:
- Dose Expansion Phase: this part of the study will test different dose levels of the study drug to find out which specific dose(s) seem to be most effective.
- Chemo Combination Therapy Phase: this part of the study will test how the study drug works when it is combined with the typical chemotherapy regimens that are used to treat your type of cancer.
- ICI (Immune Checkpoint Inhibitors) Combination Therapy Phase: this part of the study will test how the study drug works when it is combined with the typical immunotherapy regimens that are used to treat your type of cancer.
If you choose to join this study, the phase in which you participate will depend on when you join. The study team can let you know what phase of the study is enrolling before you make your decision.
Study Details
Full Title
Phanes Therapeutics / “The SKYBRIDGE study, an Open-label, Multicenter, Dose Escalation and Dose Expansion Phase 1/2 Study with PT217 Followed by a Key ChemotherapY and/or Checkpoint Inhibitor ComBination in Patients with NeuRoendocrIne Carcinomas That Are Known to Be DLL3 ExpressinG CancErs
Principal Investigator
Especialista en oncología médica
Protocol Number
IRB:
PRO00117090
NCT:
NCT05652686
Phase
Phase
I/II
ClinicalTrials.gov
View on ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción