NCT06386146

JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Jacobio Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.

Detailed description

This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	JAB-30355	Oral administration
DRUG	JAB-30355	Oral administration

Timeline

• Start date: 2024-07-24
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2024-04-26
• Last updated: 2026-01-22

Locations

13 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study