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

Last updated: January 16, 2026
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Digestive System Neoplasms

Neoplasms

Treatment

JAB-23E73

Clinical Study ID

NCT06959615
JAB-23E73-1001
  • All Genders

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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Unable to swallow oral medications or with gastrointestinal dysfunction orgastrointestinal 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.

Study Design

Total Participants: 334
Treatment Group(s): 1
Primary Treatment: JAB-23E73
Phase: 1/2
Study Start date:
November 22, 2024
Estimated Completion Date:
August 31, 2027

Study Description

Study JAB-23E73-1001 is a global multicenter, open-label Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anticancer activity of JAB-23E73 as a single agent in adult patients with advanced solid tumors with KRAS alteration. This study consists of a Phase 1a dose-escalation, followed by Phase 1b dose-expansion (dose optimization) and Phase 2a indication expansion. After completing dose-escalation, the MTD or preliminary RP2D of JAB-23E73 will be determined. Then, two of the alternative dosages of JAB-23E73 will be selected to further evaluate the efficacy, safety and PK in patients with KRAS-alternated NSCLC or other tumors, and patients may be further selected by certain/several types of KRAS-alternations based on dose escalation data. The RP2D will be determined according to the safety, efficacy and PK data from phase 1b.

Connect with a study center

  • Anhui Provincial Cancer Hospital

    Hefei 1808722, Anhui 1818058 230001
    China

    Site Not Available

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100032
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100032
    China

    Active - Recruiting

  • Beijing Chest Hospital

    Beijing 1816670, Beijing Municipality 2038349 100032
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100050
    China

    Site Not Available

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing 1816670, Beijing Municipality 2038349 100021
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing 1816670, Beijing Municipality 2038349 100032
    China

    Active - Recruiting

  • Fujian cancer Hospital

    Fuzhou 1810821, Fujian 1811017 350014
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou 1809858, Guangdong 1809935 510120
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning 1799869, Guangxi 1809867 530012
    China

    Active - Recruiting

  • National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College

    Langfang 1804540, Hebei 1808773 065000
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Haerbin, Heilongjiang 2036965 150081
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450003
    China

    Active - Recruiting

  • The First Affiliated hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520 450052
    China

    Active - Recruiting

  • Tongji Hospital

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan 1791247, Hubei 1806949 430071
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha 1815577, Hunan 1806691 200032
    China

    Site Not Available

  • Jiangsu Cancer Hospital

    Nanjing 1799962, Jiangsu 1806260 210009
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Active - Recruiting

  • The First Affiliate of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Site Not Available

  • The First Affiliated hospital of Nanchang University

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang 2034937, Liaoning 2036115 110001
    China

    Active - Recruiting

  • Fudan University Zhongshan Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    China

    Site Not Available

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200025
    China

    Site Not Available

  • ShanXi Cancer Hospital

    Taiyuan, Shanxi 650118
    China

    Site Not Available

  • ShanXi Cancer Hospital

    Taiyuan 1793511, Shanxi 1795912 650118
    China

    Active - Recruiting

  • The First Affiliated hospital of Xi'an Jiaotong University

    Xi’an 11474004, Shanxi 1795912 710061
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute&Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300211
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310005
    China

    Site Not Available

  • The Second Affiliate Hospital Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310009
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou 1808926, Zhejiang 1784764 310005
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou 1808926, Zhejiang 1784764 310014
    China

    Site Not Available

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