NCT06227377 QTX3034 in Patients With KRAS G12D Mutation
| NCT ID | NCT06227377 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Quanta Therapeutics |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2027-04-01 |
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 250 participants in total. It began in 2024-02-05 with a primary completion date of 2027-04-01.
⚠ 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
Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
Eligibility Criteria
Inclusion Criteria: * Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic * Part 1: - Advanced solid tumors with at least 1 prior systemic therapy * Evaluable or Measurable disease per RECIST 1.1. * Parts 2 and 3: Measurable disease per RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate organ function Exclusion Criteria: * Prior treatment with a KRAS inhibitor * Active brain metastases or carcinomatous meningitis * History of other malignancy within 2 years * Significant cardiovascular disease * Disease or disorder that may pose a risk to patient's safety Other protocol-defined Inclusion/Exclusion Criteria may apply
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06227377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors. 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 NCT06227377 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 NCT06227377 currently recruiting?
Yes, NCT06227377 is actively recruiting participants. Contact the research team at clinicaltrials@quantatx.com for enrollment information.
Where is the NCT06227377 trial being conducted?
This trial is being conducted at Los Angeles, United States, Denver, United States, New Haven, United States, Sarasota, United States and 10 additional locations.
Who is sponsoring the NCT06227377 clinical trial?
NCT06227377 is sponsored by Quanta Therapeutics. The trial plans to enroll 250 participants.