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

NCT06959615 · tracked via the Priya Life Science China tracker

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Phase

Phase 1/2

Started

2024-11-22

Last updated

2026-01-20

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

JAB-23E73JAB-23E73

JAB-23E73: Administered orally

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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Phase 1: Number of participants with dose limiting toxicities (DLT) — Up to 21 days
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.
Phase 2a: Objective response rate (ORR) — Up to approximately 2 years
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.

Trial sites (32)

Facility	City	Region	Status
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

More Jacobio Pharmaceuticals Co., Ltd. trials in China

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A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors Recruiting

Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations Recruiting

JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation Recruiting

A Phase IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis Starting soon

Other trials for the same condition

A Study of EOC237 in Patients With Advanced Solid Tumor Recruiting

Study of AXT-1003 in Subjects With Advanced Malignant Tumors. Recruiting

A Phase I Study of SHR-4712 in Patients With Advanced Solid Tumors Active, not recruiting

An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors Recruiting

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06959615 on ClinicalTrials.gov ↗ ← All trials in China