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
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Must be able to provide an archived tumor sample
• Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor
⁃ Dose Expansion phase cohorts must meet specific expression or gene mutation where indicated
• Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition
• Must have at least 1 measurable lesion per RECIST v1.1
• Must have adequate organ functions
• Must be able to swallow and retain orally administered medication
Locations
United States
Michigan
Henry Ford Health System
RECRUITING
Detroit
Missouri
Washington University
RECRUITING
St Louis
Texas
Mary Crowley Cancer Research
RECRUITING
Dallas
Utah
University of Utah Huntsman Cancer Institute
RECRUITING
Salt Lake City
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
Shandong Cancer Hospital
RECRUITING
Jinan
Contact Information
Primary
Jacobio Pharmaceuticals
clinicaltrials@jacobiopharma.com
(781) 918-6670
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2027-08
Participants
Target number of participants: 102
Treatments
Experimental: JAB-2485 monotherapy, Phase 1, Dose Escalation
Dose escalation of JAB-2485 will be administered as monotherapy to determine the MTD and RP2D.
Experimental: JAB-2485 monotherapy, Phase 2a, Dose Expansion
JAB-2485 will be administered as monotherapy in patients with specific tumor types to evaluate the preliminary antitumor activity.
Related Therapeutic Areas
Sponsors
Leads: Jacobio Pharmaceuticals Co., Ltd.