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New treatment option for KRAS P.G12C
Official title Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
ClinicalTrials.gov ID: NCT05288205
What this study is testing
What is JAB-21822?
JAB-21822 is an investigational medicine, being studied as a potential treatment for kras p.g12c.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
- people with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors harboring KRAS p.G12C mutation who have...
- Expected survival ≥ 3 months;
- people 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...
- Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
You likely can't join if
- Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in...
- 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...
- 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...
- people who have impaired cardiac functions or clinically significant cardiac diseases;
See the full eligibility criteria
- A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
- people 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...
- Expected survival ≥ 3 months;
- people 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...
- Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
- The organ functions of people meet the criteria for the following laboratory parameters at screening;
- people must be able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption
- 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...
- 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...
- 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;
- people who have impaired cardiac functions or clinically significant cardiac diseases;
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Shenyang, Liaoning, China
- Hohhot, Neimenggu, China
- Jinan, Shandong, China
- Linyi, Shandong, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.