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

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.

Interventions

• JAB-23E73 · DRUG

  Administered orally

• JAB-23E73 · DRUG

  Administered orally

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (32)

• 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