A Phase 1/2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JAB-23E73 in Adult Patients With Advanced Solid Tumors With KRAS Alteration
Jacobio Pharmaceuticals Co., Ltd.
Summary
This study is to evaluate the safety and tolerability of pan-KRAS inhibitor JAB-23E73 in adult participants with advanced solid tumors
Description
Study JAB-23E73-1002 is a multicenter, open-label Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anticancer activity of JAB-23E73 as a single agent in adult patients with advanced solid tumors with KRAS alteration. This study consists of a Phase 1a dose-escalation, followed by Phase 1b dose-expansion and Phase 2a indication expansion. After completing dose-escalation, the MTD or preliminary RP2D of JAB-23E73 will be determined. The RP2D will be determined according to the safety, efficacy and PK data from phase 1b. The indication expa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent. * Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF). * Histologically or cytologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative interventions. * Patients must have KRAS alterations. * Participants are required to provide an archived tumor sample. * Patients with a life expectancy ≥3 months. * ECOG performance status score of 0 or 1. * Patients must have at least one measurable lesion as defined by RECIST v1.1. Exclusion Criteria: * Inability to swallow or…
Interventions
- DrugJAB-23E73
Oral administration
- DrugJAB-23E73
Oral administration
- DrugJAB-23E73
Oral administration
Locations (4)
- Mayo ClinicRochester, Minnesota
- Washington UniversitySt Louis, Missouri
- Cleveland Clinic FoundationCleveland, Ohio
- Huntsman Cancer InstituteSalt Lake City, Utah