JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration

Recruiting · NCT06973564 · Interventional (participants receive a specific treatment) · Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.

Interventions studied

JAB-23E73

This study is to evaluate the safety and tolerability of pan-KRAS inhibitor JAB-23E73 in adult participants with advanced solid tumors

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 1, Phase 2

Study type

Interventional (participants receive a specific treatment)

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.

Inability to swallow oral medications, or presence of gastrointestinal dysfunction or gastrointestinal disorders that may significantly alter the absorption of the study drug.
Patients who have previously been treated with KRAS G12C inhibitors, KRAS G12D inhibitors, or pan/multi-KRAS inhibitors.
Known serious allergy to JAB-23E73 or excipient.
Patients with primary central nervous system tumors.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures or medical intervention.
QT interval\>470 msec.
LVEF ≤50% assessed by ECHO or MUGA.

4 locations listed across 4 US states.