Tests two drugs together in advanced cancers with a KRAS G12C change
Tests two drugs together in adults with lung, colon or pancreatic cancer.
Key facts
- Who runs it
- Allist Pharmaceuticals, Inc.
- Where
- Beijing, Changsha, Fuzhou, Guangzhou, Hangzhou, Harbin, Hefei, Hohhot, Jinan, Linyi, Shanghai, Shenyang, Shenzhen, Wuhan, Xiamen, and Zhengzhou, ChinaSee the 27 sites
- Trial code
- Registry title
- Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 240 people, planned
- Started
- 14 Apr 2022
- Expected to end
- Mar 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- JAB-21822
- JAB-3312
- Record updated
- 13 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors that carry the KRAS p.G12C mutation and have no good standard treatment left.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced or metastatic solid tumors, confirmed by tissue or cell tests. At least one measurable lesion is needed. Expected survival of 3 months or more. Daily-life fitness (ECOG) of 0-1.
- Earlier treatment
- Standard treatment has failed, is not available, or the person cannot tolerate it or does not want it.
- Biomarker or test result
- KRAS p.G12C mutation
Main reasons for not taking part
- Another cancer in the past 3 years or now, with a few listed exceptions
- HIV, hepatitis B or hepatitis C positive
- Severe autoimmune disease, or long-term high-dose steroid treatment
- Recent heart attack, unstable angina or stroke, or serious heart disease
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Previous (≤ 6 months prior to the first dose) or current evidence of the following diseases: acute myocardial infarction, unstable angina and cerebrovascular accident
- HIV, hepatitis B virus(HBV), or hepatitis C virus(HCV) positive
- Subjects who have impaired cardiac functions or clinically significant cardiac diseases
- 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
- Pregnant or lactating women
Where in China
- Beijing Cancer HospitalBeijing, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdTaking people
- Beijing chest hospital, Capital Medical UniversityBeijing, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Beijing Tiantan Hospital, Captal Medical UniversityBeijing, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdTaking people
- Pecking Union Medical College HospitalBeijing, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Peking University Third HospitalBeijing, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdTaking people
- Hunan Cancer HospitalChangsha, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Xiangya Hospital Central South UnivesityChangsha, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Fujian Cancer HospitalFuzhou, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Zhujiang Hospital of Southem Medical UniversityGuangzhou, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- The Second Affiliated Hospital Zhejiang School of MedicineHangzhou, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Harbin Medical University Cancer Hospital-Mammary gland of internalHarbin, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- The First Affiliated Hospital of USTC(Anhui Provincial Hospital)Hefei, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- The Affilated Hospital of Inner Mongolia Medical UniversityHohhot, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Qilu Hospital of Shandong UniversityJinan, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Shandong Cancer HospitalJinan, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- LinYi Cancer HospitalLinyi, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Fudan University Shanghai Cancer CenterShanghai, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- The First Hospital of China Medical UniversityShenyang, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen CenterShenzhen, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Renmin Hospital of Wuhan UniversityWuhan, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Tongji Hospital Tongji Medical College of HustWuhan, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- The First Affiliated Hospital Xiamen UniversityXiamen, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
- The First Affiliated Hosipital Of Zhengzhou UniversityZhengzhou, ChinaContact: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., LtdNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Dose escalationTreatment being tested
Treatment: JAB-21822 and JAB-3312
- Dose expansionTreatment being tested
Treatment: JAB-21822 and JAB-3312
Results explained
A paper that names this trial, explained in plain words.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1/2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
- Plain-language title
- Tests two drugs together in advanced cancers with a KRAS G12C changeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Record updated
- 13 August 2026