Phase 1: testing QTX3034 for Solid Tumors
Phase 1 study to determine the whether it is safe and how hard side effects are to live with of QTX3034 as a single agent or in combination with cetuximab.
Official registry: https://clinicaltrials.gov/study/NCT06227377 · Quanta Therapeutics · enrollment listed as 250
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are QTX3034, or Cetuximab. The registry lists allocation as randomized. Phase 1 study to determine the whether it is safe and how hard side effects are to live with of QTX3034 as a single agent or in combination with cetuximab.
They plan to enroll about 250 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Interventions: QTX3034, Cetuximab
Primary outcome (registry wording): Number of participants with Dose Limiting Toxicities (DLTs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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/
Public study contact (from the registry)
Quanta Therapeutics Clinical Trials
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
14 listed- UCLA Hematology/Oncology — Los Angeles, California (recruiting)
- Sarah Cannon Research Institute (SCRI) — Denver, Colorado (recruiting)
- Yale Cancer Center — New Haven, Connecticut (recruiting)
- Florida Cancer Specialists — Sarasota, Florida (recruiting)
- Moffitt Cancer Center — Tampa, Florida (recruiting)
- NYU Langone Health — New York, New York (recruiting)
- Montefiore Medical Center — The Bronx, New York (recruiting)
- Duke University — Durham, North Carolina (recruiting)
- Stephenson Cancer Center — Oklahoma City, Oklahoma (recruiting)
- SCRI- Nashville — Nashville, Tennessee (recruiting)
- MD Anderson — Houston, Texas (recruiting)
- START San Antonio, LLC — San Antonio, Texas (recruiting)
FAQ about this NCT record
Is NCT06227377 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06227377?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06227377?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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