QTX3544 + Cetuximab for Cancer

Recruiting at 9 trial locations

Overseen By Quanta Therapeutics Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Quanta Therapeutics

Disqualifiers: Brain metastasis, Cardiovascular disease, Infection, others

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

Compensation: Varies

Number of Visits: Unknown

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

237 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of a new drug, QTX3544, used alone or with cetuximab (a targeted therapy) for treating certain advanced cancers. Researchers focus on cancers with the KRAS G12V genetic mutation, which have been difficult to treat. Ideal participants have advanced solid tumors, have undergone at least one systemic cancer treatment, and have confirmed the KRAS G12V mutation through a lab test. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 QTX3544 is being tested for safety and effectiveness. It targets specific changes in cancer cells. Currently, limited information exists about its safety in humans, as it remains in the early testing stages. This phase primarily focuses on assessing safety and determining a dose that avoids harm.

When combined with cetuximab, it is important to note that cetuximab has been used with other treatments before. Common side effects of cetuximab include skin rash, diarrhea, and tiredness. In rare cases, it can cause serious lung issues.

As this is an early phase study, complete safety data for humans is not yet available. The trial's main goal is to find a safe dose and identify any side effects. Prospective participants should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about QTX3544 because it represents a novel approach to cancer treatment. Unlike standard therapies that often target cancer cells broadly, QTX3544 is designed to be more precise in its action, potentially leading to fewer side effects. This drug can be used both on its own and in combination with cetuximab, a well-known cancer treatment, which might enhance its effectiveness. The combination with cetuximab could offer a new option for patients who have not responded well to existing treatments.

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

Research has shown that QTX3544 is very effective against several KRAS gene changes, especially G12V, in early lab studies. This suggests it might work well for certain types of cancer. In this trial, some participants will receive QTX3544 alone, while others will receive it in combination with cetuximab. Studies have shown that using QTX3544 with cetuximab significantly enhances cancer-fighting effects, leading to greater tumor shrinkage, particularly in pancreatic cancer. Cetuximab has already shown some success in treating cancers like colorectal and non-small-cell lung cancer. Combining it with QTX3544 could provide a more powerful treatment due to their complementary effects. While information from human studies is still being gathered, these findings strongly suggest potential effectiveness. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12V. They must have measurable disease and should have tried at least one systemic therapy before. The study excludes those without the specified mutation or who don't meet measurement criteria.

Inclusion Criteria

I have advanced cancer and have received at least one treatment.

My cancer can be measured by standard health scans.

My cancer has a KRAS G12V mutation as confirmed by a certified test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

QTX3544 is administered as monotherapy or in combination with cetuximab based on cohort assignment

21 days for initial dose limiting toxicity assessment, up to 2 years for overall treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Cetuximab
• QTX3544

Trial Overview The trial is testing QTX3544, alone or combined with cetuximab, to see how safe it is and if it can shrink tumors. It's an early-phase study, meaning they're just starting to understand how these treatments work in people with certain cancer types.

How Is the Trial Designed?

Group I: Part 3: QTX3544 dose expansion in combination with cetuximab Experimental Treatment 2 Interventions

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Group II: Part 2: QTX3544 monotherapy dose expansion Experimental Treatment 1 Intervention

QTX3544 will be administered at protocol defined dose based on cohort assignment

Group III: Part 1b: QTX3544 dose escalation in combination with cetuximab Experimental Treatment 2 Interventions

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Group IV: Part 1a: QTX3544 monotherapy dose escalation Experimental Treatment 1 Intervention

QTX3544 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]

A new enzyme-linked immunosorbent assay was developed to accurately measure cetuximab serum concentrations, which is important for understanding individual responses to treatment in patients with metastatic colorectal cancer.

In a study of 16 patients, the assay showed median trough and peak cetuximab concentrations of 49.6 mg/L and 177.2 mg/L, respectively, indicating that this method can effectively support therapeutic drug monitoring and pharmacokinetic studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An enzyme-linked immunosorbent assay for therapeutic drug monitoring of cetuximab. Cézé, N., Ternant, D., Piller, F., et al.[2015]

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 targeting the epidermal growth factor receptor (EGFR), has shown improved survival rates in patients with locally advanced head and neck carcinoma when combined with radiotherapy, pending FDA approval.

In previously treated non-small cell lung cancer, cetuximab demonstrated a modest objective response rate of 4.5% and a median survival of 8.1 months, with treatment being well tolerated despite skin rash being the main side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolving role of cetuximab in non-small cell lung cancer. Lilenbaum, RC.[2020]

In a Phase II clinical trial involving 57 patients with chemotherapy-refractory colorectal cancer, cetuximab demonstrated modest antitumor activity, with 9% of patients achieving a partial response and a median survival of 6.4 months.

Cetuximab was generally well-tolerated, with common side effects including an acne-like rash and fatigue, but serious adverse events were rare, indicating a favorable safety profile for this treatment in patients with EGFr-expressing tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. Saltz, LB., Meropol, NJ., Loehrer, PJ., et al.[2022]

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 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]

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]

Citations

1. quantatx.com quantatx.com/news/042825/

April 28, 2025 Press Release “QTX3544 has shown high potency against multiple KRAS variants, particularly G12V. These preclinical data support the clinical strategy to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06715124

Study Details | NCT06715124 | QTX3544 in Patients With ... The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose.

3. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/quantas-qtx3544-a-powerful-new-oral-multi-kras-inhibitor/

Quanta's QTX3544: A Powerful New Oral Multi-KRAS ... Quanta Therapeutics will present data on QTX3544, an oral, G12V-preferring, multi-KRAS inhibitor, at the 2025 AACR Annual Meeting.

4. withpower.com withpower.com/trial/qtx3544-cetuximab-for-cancer-71a5e

QTX3544 + Cetuximab for Cancer Cetuximab has shown some effectiveness in treating certain cancers, like colorectal cancer and non-small-cell lung cancer, especially when combined with other ...

5. finance.yahoo.com finance.yahoo.com/news/quanta-therapeutics-presents-breaking-data-120000287.html

Quanta Therapeutics Presents Late-Breaking Data for ... Combination treatment of QTX3544 with cetuximab significantly enhanced anti-tumor efficacy and elicited greater tumor regressions in pancreatic ...

6. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/LB430/761502/Abstract-LB430-QTX3544-a-potent-and-selective-G12V

Abstract LB430: QTX3544, a potent and selective G12V ... Co-administration of QTX3544 and cetuximab significantly enhanced anti-tumor efficacy and elicited greater tumor regressions in the Capan-2 ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/560388

QTX3544 in Patients With Advanced Solid Tumors ... Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.