Clinical Trials in China / NCT06959615
Recruiting
Phase 1/2
A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
NCT06959615 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Solid Tumor
Investigational drug(s) / intervention(s)
JAB-23E73: Administered orally
JAB-23E73: Administered orally
Study summary
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.
Eligibility
Inclusion Criteria:
1. 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).
2. Able to provide an archived tumor tissue sample or fresh biopsy sample.
3. Life expectancy ≥3 months at the start of treatment.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. ≥1 measurable lesion per RECIST v1.1.
6. Adequate organ function.
Exclusion Criteria:
1. Unable to swallow oral medications or with gastrointestinal dysfunction or gastrointestinal disease that significantly alters the absorption of medication.
2. Previous treatment with rat sarcoma (RAS) targeting agents.
3. Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
4. Impaired cardiovascular function or clinically significant cardiac disease.
5. Mean QT interval corrected using Fridericia's formula (QTcF) \>470 msec.
6. Females who are pregnant or breastfeeding.
Primary outcome measure(s)
- Phase 1: Number of participants with dose limiting toxicities (DLT) — Up to 21 days
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. DLTs will be defined as the occurrence of any of the toxicities as described in the protocol. - Phase 2a: Objective response rate (ORR) — Up to approximately 2 years
ORR is defined as the proportion of patients with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1.
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| Anhui Provincial Cancer Hospital | Hefei | Anhui | Not Yet Recruiting |
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | Recruiting |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Chest Hospital | Beijing | Beijing Municipality | Recruiting |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | Not Yet Recruiting |
| Fujian cancer Hospital | Fuzhou | Fujian | Not Yet Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Recruiting |
| Guangxi Medical University Cancer Hospital | Nanning | Guangxi | Recruiting |
| National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College | Langfang | Hebei | Recruiting |
| Harbin Medical University Cancer Hospital | Haerbin | Heilongjiang | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| The First Affiliated hospital of Zhengzhou University | Zhengzhou | Henan | Recruiting |
| Tongji Hospital | Wuhan | Hubei | Not Yet Recruiting |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Not Yet Recruiting |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | Recruiting |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | Not Yet Recruiting |
| Jiangsu Province Hospital | Nanjing | Jiangsu | Recruiting |
| The First Affiliate of Soochow University | Suzhou | Jiangsu | Not Yet Recruiting |
| The First Affiliated hospital of Nanchang University | Nanchang | Jiangxi | Recruiting |
| The First Hospital of China Medical University | Shenyang | Liaoning | Recruiting |
| Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| Fudan University Zhongshan Hospital | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| ShanXi Cancer Hospital | Taiyuan | Shanxi | Recruiting |
| The First Affiliated hospital of Xi'an Jiaotong University | Xi’an | Shanxi | Not Yet Recruiting |
| West China Hospital, Sichuan University | Chengdu | Sichuan | Not Yet Recruiting |
| Tianjin Medical University Cancer Institute&Hospital | Tianjin | Tianjin Municipality | Not Yet Recruiting |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | Recruiting |
| The Second Affiliate Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06959615 on ClinicalTrials.gov ↗ ← All trials in China