NCT05490472

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Jacobio Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of JAB-2485 monotherapy to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) during Dose Escalation phase when administered in participants with advanced solid tumors; then to further evaluate preliminary antitumor activity of JAB-2485 monotherapy at the RP2D during Dose Expansion phase in patients with advanced solid tumors such as ER+ breast cancer, triple negative breast cancer (TNBC), AT-rich interaction domain 1A (ARID1A) mutant solid tumors and small cell lung cancer (SCLC).

Conditions

• Solid Tumors
• ER+ Breast Cancer
• Triple Negative Breast Cancer, TNBC
• ARID1A Gene Mutation
• Small Cell Lung Cancer, SCLC

Interventions

Type	Name	Description
DRUG	JAB-2485 (Aurora A inhibitor)	Administered orally
DRUG	JAB-2485 (Aurora A inhibitor)	Administered orally

Timeline

• Start date: 2022-12-20
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2022-08-05
• Last updated: 2026-01-09

Locations

8 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study