Glecirasib plus sitneprotafib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 1/2a trial.
Jia Zhong, Jun Zhao, Jianchun Duan...
https://pubmed.ncbi.nlm.nih.gov/41325755Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05288205
Phase 1/2a Study Evaluating Safety, Pharmacokinetics, and Antitumor Activity of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
Led by Allist Pharmaceuticals, Inc. · Updated on 2025-04-04
240
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of two drugs, JAB-21822 and JAB-3312, in patients with advanced solid tumors that have a specific KRAS p.G12C mutation. This phase 1/2a study includes patients whose cancers have failed standard treatments or who cannot use them. The study aims to find the recommended dose for these drugs combined and to explore their preliminary effects and safety in certain cancers with this mutation. The trial has two parts: a dose escalation phase to find the right dose and test safety, followed by a dose expansion phase to further assess safety and early effectiveness at that dose. Participants receive the combination of JAB-21822, a KRAS G12C inhibitor, and JAB-3312, an SHP2 inhibitor. Both drugs are taken orally. The dose escalation phase identifies the recommended phase 2 dose (RP2D), and the expansion phase studies that dose in specific cancers. During the study, participants undergo assessments including monitoring for dose limiting toxicities, adverse events, and tumor response. Researchers use imaging and standard criteria to measure tumor changes. They also track progression-free survival and collect safety data. Participants are followed for about two years to evaluate outcomes and drug effects. The study is open-label and non-randomized, enrolling adults aged 18 and older with certain advanced cancers.
CONDITIONS
Brief Title
Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors with KRAS p.G12C mutation
- Failed or lack standard-of-care treatment, or unwilling/intolerant to standard-of-care
- Expected survival of at least 3 months
- At least one measurable lesion per RECIST v1.1 or a progressing lesion treated with radiation at least 4 weeks prior
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function per laboratory criteria at screening
- Ability to swallow oral medications without gastrointestinal issues affecting absorption
You will not qualify if you...
- Previous or current tumors of other pathological types within 3 years, except certain cured or non-recurrent cancers
- Serious allergy to study drugs or excipients
- Previous or current severe autoimmune diseases or those requiring long-term immunosuppressive therapy
- Positive for HIV, hepatitis B, or hepatitis C virus
- Recent (within 6 months) or current acute myocardial infarction, unstable angina, or cerebrovascular accident
- Impaired cardiac functions or clinically significant cardiac diseases
- Pregnant or lactating women
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 2 years
Participants receive the study drugs JAB-21822 and JAB-3312 as part of the treatment for their advanced solid tumors harboring the KRAS p.G12C mutation.
Trial Site Locations
Total: 27 locations
1
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
Pecking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Not Yet Recruiting
3
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
4
Beijing Tiantan Hospital, Captal Medical University
Beijing, Beijing Municipality, China, 100070
Not Yet Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
6
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
7
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101125
Not Yet Recruiting
8
Fujian cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
9
The First Affiliated Hospital Xiamen University
Xiamen, Fujian, China, 361003
Not Yet Recruiting
10
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
11
Zhujiang Hospital of Southem Medical University
Guangzhou, Guangdong, China, 510280
Not Yet Recruiting
12
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
Shenzhen, Guangdong, China, 518116
Not Yet Recruiting
13
Harbin Medical University Cancer Hospital-Mammary gland of internal
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
14
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
15
The First Affiliated Hosipital Of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
16
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
17
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, China, 430030
Not Yet Recruiting
18
Renmin Hospital Of Wuhan University
Wuhan, Hubei, China, 430060
Not Yet Recruiting
19
Xiangya Hospital Central South Univesity
Changsha, Hunan, China, 410008
Not Yet Recruiting
20
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
21
The First Hospital Of China Medical University
Shenyang, Liaoning, China, 110001
Not Yet Recruiting
22
The Affilated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, China, 750306
Not Yet Recruiting
23
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
24
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
25
LinYi Cancer Hospital
Linyi, Shandong, China, 276002
Not Yet Recruiting
26
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
27
The Second Affiliated Hospital Zhejiang School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
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Research Team
S
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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JAB-3312, a Potent Allosteric SHP2 Inhibitor That Enhances the Efficacy of RTK/RAS/MAPK and PD-1 Blockade Therapies.
Di Kang, Yanping Wang, Yiwei Lin...
https://pubmed.ncbi.nlm.nih.gov/40333694