QTX3544 + Cetuximab for Cancer

Recruiting at 5 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

Trial Summary

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.

What data supports the effectiveness of the drug combination QTX3544 and 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 treatments. It has been approved for use in colorectal cancer and has shown a small benefit in lung cancer when used with chemotherapy. ^{1 2 3 4 5}

What safety data exists for Cetuximab in humans?

Cetuximab has been studied in various cancers, and common side effects include skin rash, diarrhea, and fatigue. Rarely, it can cause serious lung problems, as seen in a case of fatal interstitial lung disease. Overall, it is generally well-tolerated, but patients should be aware of potential serious side effects. ^{1 2 3 6 7}

What makes the drug QTX3544 + Cetuximab unique for cancer treatment?

The combination of QTX3544 with Cetuximab is unique because Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), which is effective in certain cancers like colorectal cancer. This combination may offer a novel approach by potentially enhancing the effectiveness of Cetuximab, although specific details about QTX3544's role are not provided in the available research. ^{1 2 3 8 9}

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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, 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]

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]

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, 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cetuximab in non-small-cell lung cancer. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Two cases of acneiform eruption induced by inhibitor of epidermal growth factor receptor. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. [2022]

6. France pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Topical aloe vera for the treatment of cetuximab-related acneiform rash in colorectal cancer: A case report. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

An enzyme-linked immunosorbent assay for therapeutic drug monitoring of cetuximab. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Impact of cetuximab in current treatment of metastatic colorectal cancer. [2018]