A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT06959615

Run by

Jacobio Pharmaceuticals Co., Ltd.

People needed

334

Starts

2024-11-22

Expected to finish

2027-08-31

Last updated by the study team

2026-01-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (enrolling)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College — Langfang, Hebei, China (enrolling)
• ShanXi Cancer Hospital — Taiyuan, Shanxi, China (enrolling)
• Harbin Medical University Cancer Hospital — Haerbin, Heilongjiang, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• The First Affiliated hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
• Beijing Chest Hospital — Beijing, Beijing Municipality, China (enrolling)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (enrolling)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Fujian cancer Hospital — Fuzhou, Fujian, China
• Tongji Hospital — Wuhan, Hubei, China
• Hunan Cancer Hospital — Changsha, Hunan, China
• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China
• The First Affiliate of Soochow University — Suzhou, Jiangsu, China
• Shanghai Jiaotong University School of Medicine Ruijin Hospital — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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