Status:
RECRUITING
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
Lead Sponsor:
Jacobio Pharmaceuticals Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of JAB-23E73 in patients with advanced ...
Eligibility Criteria
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.
Key Trial Info
Start Date :
November 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT06959615
Start Date
November 22 2024
End Date
August 31 2027
Last Update
May 6 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
3
ShanXi Cancer Hospital
Taiyuan, Shanxi, China, 650118
4
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005