RecruitingPhase 1Phase 2NCT06973564

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

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

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Enrollment

294 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria7

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.