250 Participants Needed

QTX3034 + Cetuximab for Solid Tumors

Recruiting at 16 trial locations
QT
Overseen ByQuanta Therapeutics Clinical Trials
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new drug, QTX3034, is safe and tolerable for individuals with certain advanced solid tumors. It targets cancers with a specific change in the KRAS gene, commonly found in many solid tumors. The trial will test QTX3034 both alone and in combination with another cancer drug, cetuximab. Individuals with these tumors who have tried at least one other cancer treatment may be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that QTX3034, whether used alone or with cetuximab, is generally safe. In studies, patients tolerated it well, and clear evidence indicates that the treatment works as expected. These findings suggest that the treatment is usually well-tolerated, with no major safety issues reported. This information comes from early trials focusing on safety and how the treatment works in the body. Prospective participants in a clinical trial for QTX3034 may find these results encouraging. However, it is important to consult a healthcare provider to understand what this could mean personally.12345

Why are researchers excited about this trial's treatments?

QTX3034 is unique because it targets solid tumors with a novel mechanism, potentially offering a new angle of attack compared to existing chemotherapy and targeted therapies like cetuximab alone. Most treatments for solid tumors work by either directly killing cancer cells or blocking growth signals. However, QTX3034, when combined with cetuximab, might enhance the efficacy of cetuximab by specifically targeting additional pathways involved in tumor growth and resistance. Researchers are excited because this combination could lead to more effective treatments with potentially fewer side effects, offering new hope for patients with hard-to-treat solid tumors.

What evidence suggests that this trial's treatments could be effective for solid tumors?

Research has shown that QTX3034, when combined with cetuximab, has promising effects against certain cancers. One study found that three out of twelve patients experienced tumor shrinkage, particularly those with pancreatic ductal cancer. The combination also proved effective against tumors in patients with colorectal cancer. In this trial, participants will receive either QTX3034 alone or in combination with cetuximab. Although these results are preliminary, they suggest that QTX3034, especially with cetuximab, might help treat these challenging cancers.12367

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have a specific KRAS G12D mutation, confirmed by certified testing. Participants must have tried at least one systemic therapy before and should be in good physical condition (ECOG status 0 or 1). They need to have measurable disease as defined by RECIST criteria and their organs must function well.

Inclusion Criteria

I am fully active or can carry out light work.
My cancer is advanced or has spread, and tests show a KRAS G12D mutation.
For Parts 2 and 3: Measurable disease per RECIST 1.1
See 7 more

Exclusion Criteria

I have a serious heart condition.
I have active brain tumors or cancer in the lining of my brain.
I have had another type of cancer in the last 2 years.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive QTX3034 as monotherapy or in combination with cetuximab in dose-escalation and dose-expansion phases

up to 21 days for initial dose-limiting toxicity assessment, followed by up to 2 years for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events and duration of response

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • QTX3034
Trial Overview The study is evaluating the safety of QTX3034 alone or when used together with cetuximab. It's an early-stage (Phase 1) trial aimed at understanding how patients tolerate these treatments and determining appropriate dosages.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Part 3: QTX3034 combination with cetuximab dose-expansionExperimental Treatment2 Interventions
Group II: Part 2: QTX3034 monotherapy dose-expansionExperimental Treatment1 Intervention
Group III: Part 1b: QTX3034 combination with cetuximab dose-escalationExperimental Treatment2 Interventions
Group IV: Part 1a: QTX3034 monotherapy dose-escalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Quanta Therapeutics

Lead Sponsor

Trials
3
Recruited
730+

Published Research Related to This Trial

Cetuximab, an anti-EGF receptor monoclonal antibody, showed no dose-limiting toxicities in Phase I studies and was well-tolerated, with common side effects including skin toxicity, diarrhea, and fatigue.
While Phase III trials indicated only a small overall survival benefit when cetuximab was added to chemotherapy, a subgroup analysis suggested a significant survival advantage in patients with high EGF receptor expression, potentially paving the way for its use in advanced non-small-cell lung cancer treatment.
Cetuximab in non-small-cell lung cancer.Carillio, G., Montanino, A., Costanzo, R., et al.[2018]
Cetuximab monotherapy is a feasible treatment option for patients with metastatic colorectal cancer (MCRC) who are intolerant to irinotecan, with no severe adverse events reported in the study of 22 patients.
The efficacy of cetuximab was modest, with a response rate of only 9.1% and median overall survival of 3.5 months, indicating a need for more effective therapies for this patient group, especially since most had wild-type KRAS tumors.
Retrospective analysis of cetuximab monotherapy for patients with irinotecan-intolerant metastatic colorectal cancer.Mizota, A., Shitara, K., Kondo, C., et al.[2021]
Cetuximab, an EGFR inhibitor, is effective in treating RAS wild type metastatic colorectal cancer but often causes significant skin toxicities, such as acneiform rash, affecting patient quality of life.
In a case study of a 60-year-old male patient, topical aloe vera extract was found to significantly reduce cetuximab-related acneiform rash, suggesting it may be a safe and effective alternative treatment for managing this common side effect.
Topical aloe vera for the treatment of cetuximab-related acneiform rash in colorectal cancer: A case report.Gürbüz, M., Akkuş, E., Utkan, G.[2021]

Citations

QTX3034 in Patients With KRAS G12D MutationPhase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab. Official Title. A Phase 1 Trial Evaluating ...
Triple meeting 2025 – early efficacy signs for QuantaIn the same study, Erbitux plus QTX3034 1,200mg twice daily led to three confirmed responses among 12 patients, two in pancreatic ductal ...
October 24, 2025 Press ReleaseThe QTX3034-cetuximab combination displayed compelling anti-tumor activity, including several responses in patients with colorectal cancer (CRC) ...
QTX3034 in Patients With KRAS G12D MutationPhase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.
QTX3034 + Cetuximab for Solid TumorsThe efficacy of cetuximab was modest, with a response rate of only 9.1% and median overall survival of 3.5 months, indicating a need for more effective ...
Quanta Therapeutics Presents Positive Phase 1 Data for ...QTX3034 monotherapy and the QTX3034-cetuximab combination demonstrated favorable safety profiles and clear clinical proof of concept, ...
Positive Ph 1 Data for QTX3034 in Patients with Advanced ...“QTX3034's unique multi-KRAS activity coupled with an encouraging safety profile have delivered compelling clinical signals with both ...
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