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

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

Phase1; Phase2 Interventional Allist Pharmaceuticals, Inc. · NCT05288205

This study is testing a new combination of drugs, JAB-21822 and JAB-3312, to see if it helps people with advanced solid tumors that have a specific KRAS mutation.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorAllist Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionsradiation, prednisone
Locations27 sites (Hefei, Anhui and 26 other locations)
Trial IDNCT05288205 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors that have the KRAS p.G12C mutation and have either failed standard-of-care treatments or are intolerant to them.

Not a fit: Patients without the KRAS p.G12C mutation or those with early-stage tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring the KRAS p.G12C mutation.

How similar studies have performed: While there have been studies targeting KRAS mutations, this specific combination therapy approach is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Hefei, Anhui and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions KRAS P.G12CNon-small Cell Lung CancerColorectal CancerPancreatic Ductal Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.