Evaluating ZG2001 for KRAS Mutated Advanced Solid Tumors
A Phase I/II Dose Escalation Study to Evaluating the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG2001 Tosilate Tablets in Participants With KRAS Mutated Advanced Solid Tumours
This study is testing a new treatment called ZG2001 to see if it can help people with advanced solid tumors that have a KRAS mutation and who haven't had success with other therapies.
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 | NCT06237413 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of ZG2001 in patients with advanced solid tumors that have a KRAS mutation. Participants must have progressed on or be ineligible for all known therapies that could provide clinical benefit. The study aims to gather data on how well ZG2001 works in this specific patient population. It is designed as an interventional trial, encompassing both Phase 1 and Phase 2 assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with KRAS mutant solid tumors who have not responded to or are ineligible for existing therapies.
Not a fit: Patients who have received SOS1 inhibitors or have hypersensitivity to the study drug's components 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 mutated tumors that currently have limited treatment options.
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: * Participants who fully understood this study and voluntarily signed the informed consent form; * Men or women ≥ 18 years old; * Participants with a KRAS mutant solid tumor should have progressed on or are ineligible for all therapy(ies) known to confer clinical benefit. * ECOG Performance Status (PS) 0 or 1; * Life expectancy \> 3 months. Exclusion Criteria: * Received any SOS1 inhibitors; * Participants with a known history of hypersensitivity reactions to the ingredients of the preparations used in this study; * 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.