NCT07282587

Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma

A Phase 2 Study of ONC206 in Advanced Pheochromocytoma and Paraganglioma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG).

Detailed description

Two-Stage Study to evaluate ONC206 as monotherapy doses: Stage 1: Participants will receive 150mg ONC206 twice daily, on three consecutive days per week (BID TIW) in each 28-day cycle. * Part A: Initial number of participants will be monitored. * Part B: If a set number of participants have a response, then more participants will be enrolled and treated. Stage 2: If Stage 1 meets the planned response, the study will proceed, and participants will be randomized 1:1 to receive 1 of 2 ONC206 dose levels.

Conditions

• Advanced Pheochromocytoma and Paraganglioma
• PCPG

Interventions

Type	Name	Description
DRUG	ONC206	150 mg BID TIW
DRUG	ONC206: Dose 1
DRUG	ONC206: Dose 2

Timeline

• Start date: 2026-01-02
• Primary completion: 2028-12-15
• Completion: 2028-12-15
• First posted: 2025-12-15
• Last updated: 2026-02-27

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study