QTX3034 + Cetuximab for Solid Tumors

Recruiting at 16 trial locations

Overseen By Quanta Therapeutics Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Quanta Therapeutics

Must not be taking: KRAS inhibitors

Disqualifiers: Brain metastases, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

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

250 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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

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.

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?

Group I: Part 3: QTX3034 combination with cetuximab dose-expansion Experimental Treatment 2 Interventions

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Group II: Part 2: QTX3034 monotherapy dose-expansion Experimental Treatment 1 Intervention

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Group III: Part 1b: QTX3034 combination with cetuximab dose-escalation Experimental Treatment 2 Interventions

QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Group IV: Part 1a: QTX3034 monotherapy dose-escalation Experimental Treatment 1 Intervention

QTX3034 will be administered at protocol defined dose based on cohort assignment

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical aloe vera for the treatment of cetuximab-related acneiform rash in colorectal cancer: A case report. Gürbüz, M., Akkuş, E., Utkan, G.[2021]

Cetuximab, a monoclonal antibody used to treat various cancers, can cause serious side effects, including interstitial lung disease, as demonstrated in a case where a patient developed this condition within the first 4 weeks of treatment and ultimately died.

This case emphasizes the need for healthcare professionals to be aware of the potential for early and fatal pulmonary complications associated with cetuximab, which are not commonly reported in the literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of fatal cetuximab-induced interstitial lung disease during the first weeks of treatment. Shablak, A., Conn, A.[2021]

Cetuximab (CTX) is an effective monoclonal antibody for treating head and neck and colorectal cancers, and measuring its trough levels in plasma can help personalize treatment to improve patient outcomes.

A new high-throughput method using liquid chromatography-high resolution mass spectrometry (LC-HRMS) was developed to accurately measure CTX levels in patients, demonstrating good precision and paving the way for better clinical monitoring of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of Cetuximab in Plasma by Liquid Chromatography-High-Resolution Mass Spectrometry Orbitrap With a Stable Labeled 13C,15N-Cetuximab Internal Standard. Millet, A., Lebert, D., Picard, G., et al.[2020]

Cetuximab is a chimeric monoclonal antibody that targets the epidermal growth-factor receptor (EGFR) and has been clinically approved in Europe for treating metastatic colorectal cancer and locally advanced head and neck cancer since 2004 and 2006, respectively.

The review discusses cetuximab's established role in colorectal cancer treatment, ongoing studies, and future challenges, highlighting its significance as the leading anti-EGFR monoclonal antibody in clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab: appraisal of a novel drug against colorectal cancer. Hildebrandt, B., le Coutre, P., Nicolaou, A., et al.[2019]

Cetuximab has demonstrated significant efficacy in treating metastatic colorectal cancer, achieving a partial response in 10.8% of patients receiving it alone and 22.9% when combined with irinotecan, based on a Phase III trial involving 329 patients.

The drug is generally well tolerated, with common side effects like acnelike rash and hypersensitivity reactions, but the lack of reliable predictive markers for patient selection remains a challenge for its clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab: an epidermal growth factor receptor monoclonal antibody for the treatment of colorectal cancer. Wong, SF.[2022]

Cetuximab, an anti-cancer drug that targets the epidermal growth factor receptor (EGF-R), can cause acneiform eruptions as a secondary side effect in patients with adenocarcinoma.

The skin reactions, characterized by folliculitis, responded well to topical treatments like benzoyl peroxide and erythromycin gel, indicating that these side effects can be effectively managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two cases of acneiform eruption induced by inhibitor of epidermal growth factor receptor. Gencoglan, G., Ceylan, C.[2018]

Cetuximab is an effective treatment for patients with metastatic colorectal cancer (mCRC) who have wild-type KRAS, and its use has been supported by various clinical trials assessing its impact on patient outcomes and quality of life.

The identification of KRAS mutation status is crucial for selecting patients who are most likely to benefit from cetuximab, enhancing the treatment's efficacy in managing unresectable mCRC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of cetuximab in current treatment of metastatic colorectal cancer. Sotelo Lezama, MJ., Sastre Valera, J., Díaz-Rubio García, E.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06227377

QTX3034 in Patients With KRAS G12D Mutation

Phase 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 ...

2.

oncologypipeline.com

oncologypipeline.com/apexonco/triple-meeting-2025-early-efficacy-signs-quanta

Triple meeting 2025 – early efficacy signs for Quanta

In the same study, Erbitux plus QTX3034 1,200mg twice daily led to three confirmed responses among 12 patients, two in pancreatic ductal ...

3.

quantatx.com

quantatx.com/news/102425/

October 24, 2025 Press Release

The QTX3034-cetuximab combination displayed compelling anti-tumor activity, including several responses in patients with colorectal cancer (CRC) ...

4.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/454322

QTX3034 in Patients With KRAS G12D Mutation

Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.

5.

withpower.com

withpower.com/trial/phase-1-tumors-solid-2-2024-d7d7e

QTX3034 + Cetuximab for Solid Tumors

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 ...

6.

finance.yahoo.com

finance.yahoo.com/news/quanta-therapeutics-presents-positive-phase-154500289.html

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, ...

7.

onco-this-week.com

onco-this-week.com/positive-ph-1-data-for-qtx3034-in-patients-with-advanced-solid-tumors-presented/

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 ...