Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma

Conditions

• Advanced Pheochromocytoma and Paraganglioma
• PCPG

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ONC206 — DRUG
  150 mg BID TIW
• ONC206: Dose 1 — DRUG
• ONC206: Dose 2 — DRUG

Study Details

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

Key Dates

Start date

Jan 2, 2026

Status verified

Jun 2026

Primary completion

Dec 15, 2028

Completion

Dec 15, 2028

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Stage 1 Participants
  150 mg ONC206 BID TIW
• Experimental: Stage 2: Dose 1
  Participants receiving ONC206 at dose (To be Determined \[TBD\] post stage 1).
• Experimental: Stage 2: Dose 2
  Participants receiving ONC206 at dose (TBD post stage 1).

Primary Outcome Measure

Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 36 months. ]

Central Contacts

• Clinical Trial Disclosure & Transparency
  215-832-3750
  [email protected]

Locations (9)

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