Actively Recruiting
Phase 1/2a Study 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
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Diagnosed with locally advanced or metastatic solid tumors with KRAS p.G12C mutation
- Failed, lack, unwilling to undergo, or intolerant to standard-of-care treatments
- Expected survival of at least 3 months
- Have at least one measurable lesion by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Meet required organ function laboratory criteria at screening
- Able to swallow oral medications without significant gastrointestinal issues affecting absorption
You will not qualify if you...
- Previous or current tumors of other types within 3 years except certain cured or low-risk cancers
- Serious allergy to the study drugs or their excipients
- Severe autoimmune diseases or requiring long-term immunosuppressive hormone therapy within 6 months
- Positive for HIV, hepatitis B, or hepatitis C viruses
- Acute myocardial infarction, unstable angina, or cerebrovascular accident within 6 months before treatment
- Impaired cardiac function or significant cardiac diseases
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
S
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
CONTACT
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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