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Clinical Trials in China / NCT05288205
Recruiting Phase 1/2

Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

NCT05288205 · tracked via the Priya Life Science China tracker
Sponsor
Allist Pharmaceuticals, Inc.
Phase
Phase 1/2
Started
2022-04-14
Last updated
2026-08-13

Condition(s) studied

KRAS P.G12CNon-small Cell Lung CancerColorectal CancerPancreatic Ductal Carcinoma

Investigational drug(s) / intervention(s)

JAB-21822 →JAB-3312

JAB-21822: KRAS G12C inhibitor

JAB-3312: SHP2 inhibitor

Study summary

This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed; * Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors harboring KRAS p.G12C mutation who have failed or lack standard-of-care (SOC) or are unwilling to undergo or intolerant to SOC; * Expected survival ≥ 3 months; * Subjects must have at least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the target lesion, a lesion treated with radiation ≥ 4 weeks before the first dose and with progression confirmed by radiography may be selected as the target lesion; * Eastern Cooperative Oncology Group(ECOG) performance status 0-1; * The organ functions of subjects meet the criteria for the following laboratory parameters at screening; * Subjects must be able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption Exclusion Criteria: * Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in situ of the breast, prostatic intraepithelial neoplasia, superficial non-invasive bladder cancer, stage I skin cancer (except melanoma); subjects without recurrence or metastasis for \> 3 years after treatment, without current evidence of tumor, and without significant risk of recurrence of previous malignant diseases in the opinion of the study doctor may also be enrolled; * Serious allergy to the investigational drug or excipients (such as microcrystalline cellulose, etc.); * Patients with previous (≤ 6 months before the initiation of treatment) or current severe autoimmune diseases (including adverse reactions caused by previous anti- tumor immunotherapies), or autoimmune diseases requiring long-term systemic hormone therapy at immunosuppressive dose levels (prednisone \> 10 mg/day or equivalent drugs); * HIV, hepatitis B virus(HBV), or hepatitis C virus(HCV) positive; * Previous (≤ 6 months prior to the first dose) or current evidence of the following diseases: acute myocardial infarction, unstable angina and cerebrovascular accident; * Subjects who have impaired cardiac functions or clinically significant cardiac diseases; * Pregnant or lactating women

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
The First Affiliated Hospital of USTC Anhui Provincial Hospital Hefei Anhui Not Yet Recruiting
Pecking Union Medical College Hospital Beijing Beijing Municipality Not Yet Recruiting
Cancer Hospital Chinese Academy Of Medical Sciences Beijing Beijing Municipality Recruiting
Beijing Tiantan Hospital, Captal Medical University Beijing Beijing Municipality Not Yet Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Peking University Third Hospital Beijing Beijing Municipality Recruiting
Beijing Chest Hospital, Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
Fujian cancer Hospital Fuzhou Fujian Not Yet Recruiting
The First Affiliated Hospital Xiamen University Xiamen Fujian Not Yet Recruiting
The first Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong Not Yet Recruiting
Zhujiang Hospital of Southem Medical University Guangzhou Guangdong Not Yet Recruiting
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center Shenzhen Guangdong Not Yet Recruiting
Harbin Medical University Cancer Hospital-Mammary gland of internal Harbin Heilongjiang Not Yet Recruiting
Henan Cancer Hospital Zhengzhou Henan Not Yet Recruiting
The First Affiliated Hosipital Of Zhengzhou University Zhengzhou Henan Not Yet Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei Not Yet Recruiting
Tongji Hospital Tongji Medical College of Hust Wuhan Hubei Not Yet Recruiting
Renmin Hospital Of Wuhan University Wuhan Hubei Not Yet Recruiting
Xiangya Hospital Central South Univesity Changsha Hunan Not Yet Recruiting
Hunan Cancer Hospital Changsha Hunan Not Yet Recruiting
The First Hospital Of China Medical University Shenyang Liaoning Not Yet Recruiting
The Affilated Hospital of Inner Mongolia Medical University Hohhot Neimenggu Not Yet Recruiting
Qilu Hospital of Shandong University Jinan Shandong Not Yet Recruiting
Shandong Cancer Hospital Jinan Shandong Not Yet Recruiting
LinYi Cancer Hospital Linyi Shandong Not Yet Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Not Yet Recruiting
The Second Affiliated Hospital Zhejiang School of Medicine Hangzhou Zhejiang Not Yet Recruiting

More Allist Pharmaceuticals, Inc. trials in China

Other trials for the same condition

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 NCT05288205 on ClinicalTrials.gov ↗ ← All trials in China