NCT06959615
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
Recruiting · Phase 1, Phase 2 · Jacobio Pharmaceuticals Co., Ltd. · registry updated 2026-01-20
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of pan-KRAS inhibitor JAB-23E73 in patients with advanced solid tumors harboring KRAS mutations or amplification. The study consists of 2 phases: Phase 1 Dose Escalation and Phase IIa Dose Expansion.
Inclusion
- Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer with evidence of KRAS gene alteration (including gene mutation and wild type amplification).
- Able to provide an archived tumor tissue sample or fresh biopsy sample.
- Life expectancy ≥3 months at the start of treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- ≥1 measurable lesion per RECIST v1.1.
- Adequate organ function.
Exclusion
- Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication.
- Previous treatment with rat sarcoma (RAS) targeting agents.
- Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
- Impaired cardiovascular function or clinically significant cardiac disease.
- Mean QT interval corrected using Fridericia's formula (QTcF) \>470 msec.
- Females who are pregnant or breastfeeding.