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
Jacobio Pharmaceuticals Co., Ltd.
Summary
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 ret…
Interventions
- DrugJAB-2485 (Aurora A inhibitor)
Administered orally
- DrugJAB-2485 (Aurora A inhibitor)
Administered orally
Locations (8)
- Henry Ford Health SystemDetroit, Michigan
- Washington UniversitySt Louis, Missouri
- Mary Crowley Cancer ResearchDallas, Texas
- University of Utah Huntsman Cancer InstituteSalt Lake City, Utah
- Cancer Hospital Chinese Academy of Medical SciencesBeijing, Beijing Municipality
- Peking University Third HospitalBeijing, Beijing Municipality