NCT07912593 A KRAS Inhibitor in Participants With Advanced Solid Tumors
| NCT ID | NCT07912593 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ensem Therapeutics |
| Condition | Metastatic Colorectal Cancer (CRC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2026-10-22 |
| Primary Completion | 2028-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 320 participants in total. It began in 2026-10-22 with a primary completion date of 2028-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 1/2, open-label, multi-center study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.
Eligibility Criteria
Inclusion Criteria: * Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy. * Tumor harboring a KRAS mutation. * An ECOG performance status score of 0 or 1. * Adequate organ function. Exclusion Criteria: * Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied. * Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement. * Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment. * Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy. * Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07912593 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Colorectal Cancer (CRC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07912593 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07912593 currently recruiting?
Yes, NCT07912593 is actively recruiting participants. Contact the research team at lori.cykowski@Ensemtx.com for enrollment information.
Where is the NCT07912593 trial being conducted?
This trial is being conducted at Fairfax, United States.
Who is sponsoring the NCT07912593 clinical trial?
NCT07912593 is sponsored by Ensem Therapeutics. The trial plans to enroll 320 participants.
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