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A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration Phase 1, Phase 2 334 Dose Escalation Open-Label
Clinical Trial NCT06959615 is designed to study Treatment for Advanced Solid Tumor. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on November 22, 2024, with plans to enroll 334 participants. Led by Jacobio Pharmaceuticals Co., Ltd., it is expected to complete by August 31, 2027. The latest data from ClinicalTrials.gov was last updated on January 20, 2026.
Brief 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.
Detailed 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 expansi...Show More
Official Title
A Multicenter, Open Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration
Conditions
Advanced Solid TumorOther Study IDs
- JAB-23E73-1001
NCT ID Number
Start Date (Actual)
2024-11-22
Last Update Posted
2026-01-20
Completion Date (Estimated)
2027-08-31
Enrollment (Estimated)
334
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
KRAS
KRAS mutation
KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12D
Pan-KRAS
NSCLC
Pancreas cancer
Colorectal cancer
KRAS-mutant tumor
Targeted Therapy
JAB-23E73
KRAS mutation
KRAS G12C, KRAS G12D, KRAS G12V, KRAS G12S, KRAS G12A, KRAS G12D
Pan-KRAS
NSCLC
Pancreas cancer
Colorectal cancer
KRAS-mutant tumor
Targeted Therapy
JAB-23E73
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPhase 1 Dose Exploration Monotherapy, dose escalation | JAB-23E73 Administered orally |
ExperimentalPhase 2a Dose Expansion Monotherapy, dose expansion | JAB-23E73 Administered orally |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Phase 1: Number of participants with dose limiting toxicities (DLT) | 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. | Up to 21 days |
Phase 2a: Objective response rate (ORR) | 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. | Up to approximately 2 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Phase 1/2a: Adverse events | Incidence and severity of treatment-emergent Adverse Events (TEAEs), treatment-related Adverse Events (TRAEs) and serious Adverse Events (SAEs) | Up to approximately 2 years |
Phase 1/2a: Pharmacokinetic (PK): Maximum concentration (Cmax) of JAB-23E73 | PK: Cmax of JAB-23E73 | Up to approximately 2 years |
Phase 1/2a: PK: Time to Maximum Concentration (Tmax) of JAB-23E73 | PK: Tmax of JAB-23E73 | Up to approximately 2 years |
Phase 1/2a: PK: Area Under the Concentration Versus Time Curve (AUC) of JAB-23E73 | PK: AUC of JAB-23E73 | Up to approximately 2 years |
Phase 1: ORR | ORR is defined as the proportion of patients with a BOR of confirmed CR or confirmed PR per RECIST v1.1. | Up to approximately 2 years |
Phase 1/2a: Time to Response (TTR) | TTR is defined as the time from the date of first dose of study drug to first documentation of response as assessed by the investigator per RECIST v1.1 | Up to approximately 2 years |
Phase 1/2a: Progression Free Survival (PFS) | PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first. | Up to approximately 2 years |
Phase 1/2a: Disease Control Rate (DCR) | DCR is defined as the proportion of patients with CR, PR, or stable disease (SD) as assessed by the investigator per RECIST v1.1 | Up to approximately 2 years |
Phase 1/2a: Duration of Response (DoR) | DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator. | Up to approximately 2 years |
Phase 2a: Overall Survival (OS) | OS is defined as the time from the date of first dose of study drug until the date of death from any cause. | Up to approximately 2 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
- 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.
- 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.
Jacobio Pharmaceuticals Co., Ltd.Study Central Contact
Contact: Jacobio Pharmaceuticals, 86 10 56315466, [email protected]
32 Study Locations in 1 Countries
Anhui
Anhui Provincial Cancer Hospital, Hefei, Anhui, 230001, China
Not yet recruiting
Beijing Municipality
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality, 100021, China
Recruiting
Beijing Cancer Hospital, Beijing, Beijing Municipality, 100032, China
Recruiting
Beijing Chest Hospital, Beijing, Beijing Municipality, 100032, China
Recruiting
Peking Union Medical College Hospital, Beijing, Beijing Municipality, 100032, China
Recruiting
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, 100050, China
Not yet recruiting
Fujian
Fujian cancer Hospital, Fuzhou, Fujian, 350014, China
Not yet recruiting
Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China
Recruiting
Guangxi
Guangxi Medical University Cancer Hospital, Nanning, Guangxi, 530012, China
Recruiting
Hebei
National Cancer Center/Cancer Hospital- Langfang Campus, Chinese Academy of Medical Sciences and Peking Union Medical College, Langfang, Hebei, 065000, China
Recruiting
Heilongjiang
Harbin Medical University Cancer Hospital, Haerbin, Heilongjiang, 150081, China
Recruiting
Henan
Henan Cancer Hospital, Zhengzhou, Henan, 450003, China
Recruiting
The First Affiliated hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Recruiting
Hubei
Tongji Hospital, Wuhan, Hubei, 430030, China
Not yet recruiting
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China
Recruiting
Hunan
Hunan Cancer Hospital, Changsha, Hunan, 200032, China
Not yet recruiting
Jiangsu
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China
Recruiting
Jiangsu Cancer Hospital, Nanjing, Jiangsu, 210009, China
Not yet recruiting
Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China
Recruiting
The First Affiliate of Soochow University, Suzhou, Jiangsu, 215006, China
Not yet recruiting
Jiangxi
The First Affiliated hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
Recruiting
Liaoning
The First Hospital of China Medical University, Shenyang, Liaoning, 110001, China
Recruiting
Shanghai Municipality
Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai, Shanghai Municipality, 200025, China
Not yet recruiting
Fudan University Zhongshan Hospital, Shanghai, Shanghai Municipality, 200032, China
Not yet recruiting
Huashan Hospital Fudan University, Shanghai, Shanghai Municipality, 200040, China
Not yet recruiting
Shanxi
ShanXi Cancer Hospital, Taiyuan, Shanxi, 650118, China
Recruiting
The First Affiliated hospital of Xi'an Jiaotong University, Xi’an, Shanxi, 710061, China
Not yet recruiting
Sichuan
West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China
Not yet recruiting
Tianjin Municipality
Tianjin Medical University Cancer Institute&Hospital, Tianjin, Tianjin Municipality, 300211, China
Not yet recruiting
Zhejiang
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310005, China
Recruiting
The Second Affiliate Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
Not yet recruiting
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China
Not yet recruiting