Status:
RECRUITING
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
Lead Sponsor:
Jacobio Pharmaceuticals Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is to evaluate the safety and tolerability of JAB-23E73 in adult participants with advanced solid tumors
Detailed 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 singl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT06973564
Start Date
May 29 2025
End Date
February 1 2028
Last Update
November 12 2025
Active Locations (4)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Washington University
St Louis, Missouri, United States, 63110
3
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
4
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112