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

NCT ID: NCT06959615

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-22

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1 Dose Exploration

Monotherapy, dose escalation

Group Type EXPERIMENTAL

JAB-23E73

Intervention Type DRUG

Administered orally

Phase 2a Dose Expansion

Monotherapy, dose expansion

Group Type EXPERIMENTAL

JAB-23E73

Intervention Type DRUG

Administered orally

Interventions

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JAB-23E73

Administered orally

Intervention Type DRUG

JAB-23E73

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jacobio Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Site Status NOT_YET_RECRUITING

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Chest Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Fujian cancer Hospital

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Site Status RECRUITING

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

Langfang, Hebei, China

Site Status RECRUITING

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

The First Affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Tongji Hospital

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status NOT_YET_RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

The First Affiliate of Soochow University

Suzhou, Jiangsu, China

Site Status NOT_YET_RECRUITING

The First Affiliated hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

ShanXi Cancer Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

The First Affiliated hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status NOT_YET_RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, China

Site Status NOT_YET_RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

The Second Affiliate Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Jacobio Pharmaceuticals

Role: CONTACT

86 10 56315466

Other Identifiers

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JAB-23E73-1001

Identifier Type: -

Identifier Source: org_study_id

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