Testing ZG19018 for advanced solid tumors with KRAS G12C mutation
A Phase I/II Dose Escalation and Expansion Study to Evaluating the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.
This study is testing a new drug called ZG19018 to see if it is safe and effective for adults with advanced solid tumors that have a specific KRAS G12C mutation.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06237400 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of ZG19018 in patients diagnosed with advanced solid tumors harboring the KRAS G12C mutation. It is designed as a Phase 1 and Phase 2 interventional study, focusing on understanding how well the drug can be tolerated and its potential effectiveness in this specific patient population. Participants must be adults with a life expectancy of more than three months and an ECOG performance status of 0 or 1.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with advanced solid tumors that have the KRAS G12C mutation.
Not a fit: Patients who have previously received treatment with KRAS G12C inhibitors or those with conditions deemed unsuitable by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with KRAS G12C mutant advanced solid tumors.
How similar studies have performed: While this approach is focused on a specific mutation, similar studies targeting KRAS mutations have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects who fully understood this trial and voluntarily signed the informed consent form; * Men or women ≥ 18 years old; * ECOG Performance Status (PS) 0 or 1; * Life expectancy \> 3 months. Exclusion Criteria: * Received any treatment with inhibitors against KRAS G12C mutation at any time, e.g., AMG 510, MRTX 849, etc.; * Patients requiring medications that can potentially prolong QTc interval; * Other conditions that the investigator considers to be unsuitable for participation in this study.
Where this trial is running
Beijing, Beijing
- Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Cheng Wei
- Email: weic@zelgen.com
- Phone: +86-0512-57309965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.