Testing JAB-21822 and JAB-3312 in patients with advanced solid tumors and KRAS p.G12C mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label phase 1/2a study evaluates the safety, tolerability, and pharmacokinetics of the drug combination JAB-21822 and JAB-3312 in patients with advanced solid tumors that have the KRAS p.G12C mutation. The study consists of a dose escalation phase to determine the recommended phase 2 dose (RP2D) and a dose expansion phase to further explore the efficacy and safety of the treatment at the RP2D. Participants will be monitored for their response to the therapy and any adverse effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Cancer Hospital Chinese Academy Of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of USTC Anhui Provincial Hospital
  Hefei, Anhui, China Not yet recruiting
• Pecking Union Medical College Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Tiantan Hospital, Captal Medical University
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Principal investigator: Wang Wang Jie M.D. — Peking University Cancer Hospital & Institute
• Study coordinator: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
• Email: zhenhua.gong@allist.com.cn
• Phone: 021-80423288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.