QTX3034 + Cetuximab for Solid Tumors
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Quanta Therapeutics
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called QTX3034, either by itself or with an existing cancer treatment called cetuximab. Cetuximab has been used in various cancer treatments, though its benefits have been mixed. It aims to find out if QTX3034 is safe and can help stop cancer cells from growing. The trial likely involves patients whose cancers have not responded to other treatments.
What safety data is available for QTX3034 + Cetuximab treatment?The safety data for cetuximab, a component of the treatment, indicates that common toxicities include skin reactions, diarrhea, and fatigue. In rare cases, cetuximab has been associated with severe interstitial lung disease, which can be fatal. Cetuximab is approved for certain cancers, but its use can lead to significant cutaneous toxicities impacting patient quality of life and treatment continuation. No specific safety data for QTX3034 is provided in the available research.24569
Is the drug QTX3034 a promising treatment for solid tumors?QTX3034, when combined with cetuximab, could be promising because cetuximab has shown benefits in treating certain cancers, like colorectal cancer, by targeting specific cancer cell receptors. This combination might enhance the effectiveness of QTX3034 in treating solid tumors.12357
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the idea that QTX3034 + Cetuximab for Solid Tumors is an effective treatment?The available research shows that Cetuximab, when used for treating certain types of cancer, has shown some positive results. For example, in colorectal cancer, Cetuximab has been effective for patients who did not respond to other treatments. In lung cancer, it showed a small benefit in survival when combined with chemotherapy, especially in patients with high levels of a specific protein. However, the data does not specifically mention QTX3034 combined with Cetuximab for solid tumors, so its effectiveness for this specific use is not directly supported by the information provided.13578
Eligibility Criteria
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.
I have advanced cancer and have received at least one treatment before.
Exclusion Criteria
I have a serious heart condition.
I have active brain tumors or cancer in the lining of my brain.
I have been treated with a KRAS inhibitor before.
Treatment Details
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.
4Treatment groups
Experimental Treatment
Group I: Part 3: QTX3034 combination with cetuximab dose-expansionExperimental Treatment2 Interventions
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Group II: Part 2: QTX3034 monotherapy dose-expansionExperimental Treatment1 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-escalationExperimental Treatment2 Interventions
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Group IV: Part 1a: QTX3034 monotherapy dose-escalationExperimental Treatment1 Intervention
QTX3034 will be administered at protocol defined dose based on cohort assignment
Find a clinic near you
Research locations nearbySelect from list below to view details:
Duke UniversityDurham, NC
MD AndersonHouston, TX
Sarah Cannon Research Institute (SCRI)Denver, CO
Yale Cancer CenterNew Haven, CT
More Trial Locations
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Who is running the clinical trial?
Quanta TherapeuticsLead Sponsor
References
Cetuximab: an epidermal growth factor receptor monoclonal antibody for the treatment of colorectal cancer. [2022]Cetuximab is a recombinant human/mouse chimeric epidermal growth factor receptor (EGFR) monoclonal antibody. It was approved by the US Food and Drug Administration in February 2004 to be used in combination with irinotecan for the treatment of EGFR-expressing, metastatic colorectal cancer in patients who had failed to improve with irinotecan-based chemotherapy. Cetuximab was also approved for administration as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.
Cetuximab: appraisal of a novel drug against colorectal cancer. [2019]Cetuximab (C225, Erbitux, Merck, Darmstadt, Germany) is a human-mouse chimeric therapeutic monoclonal antibody (mAb) that competitively binds to the extracellular domain of the human epidermal growth-factor receptor (EGFR). It has been developed out of the murine antibody M225 "from bench to bedside" in less than two decades, and is the anti-EGFR mAb furthest ahead in clinical evaluation. In Europe, cetuximab is approved for the treatment of patients with EGFR-expressing, metastatic colorectal cancer after failure of treatment with irinotecan since 2004, and for the treatment of patients with locally advanced squamous cell cancer of the head and neck concomitant to radiotherapy since 2006. We here summarize the current role of cetuximab in the treatment of colorectal cancer, give an overview on the ongoing studies, address the most important controversies, and point out the chances and challenges for the future use of cetuximab in colorectal cancer and other human malignancies.
Two cases of acneiform eruption induced by inhibitor of epidermal growth factor receptor. [2018]Cetuximab is a member of a new family of antineoplastic agents that inhibit the epidermal growth factor receptor (EGF-R), and which are increasingly being used in the treatment of solid tumors.
Retrospective analysis of cetuximab monotherapy for patients with irinotecan-intolerant metastatic colorectal cancer. [2021]The efficacy and safety of cetuximab for irinotecan-intolerant patients has not yet been evaluated in detail.
Cetuximab in non-small-cell lung cancer. [2018]Cetuximab is a chimeric human-mouse anti-EGF receptor monoclonal antibody. In Phase I studies, no dose-limiting toxicities were observed with cetuximab as a single agent or combined with chemotherapy; pharmacokinetic and pharmacodynamic analyses supported 250 mg/m(2) weekly administration. Skin toxicity, diarrhea and fatigue were the most common toxicities. The positive results obtained in Phase II trials in patients with advanced non-small-cell lung cancer prompted two randomized Phase III trials evaluating cetuximab in addition to first-line chemotherapy. Both trials showed a small benefit in overall survival for the experimental treatment, which was considered insufficient by the EMA for marketing approval. However, a subgroup analysis of the FLEX Phase III trial recently demonstrated a larger survival benefit from the experimental treatment in patients with high immunohistochemical EGF receptor expression. This finding, if confirmed prospectively, could represent a new opportunity for positioning cetuximab into the standard treatment of advanced non-small-cell lung carcinoma.
A case of fatal cetuximab-induced interstitial lung disease during the first weeks of treatment. [2021]Cetuximab is a monoclonal antibody targeting the epidermal growth factor receptor. It has demonstrated activity against a number of cancers including lung, head and neck, and colorectal. The most common side effects associated with this agent are dermatological; however, other types of toxicities have been reported with varying frequencies. Here, we report a case of interstitial lung disease that developed within the first 4 weeks of cetuximab treatment initiation in a patient with metastatic colorectal cancer and led to patient death. Early fatal pulmonary events secondary to cetuximab is rarely reported in the literature; this case report highlights the importance of awareness among treating health care professionals of this potentially fatal toxicity.
Impact of cetuximab in current treatment of metastatic colorectal cancer. [2018]Cetuximab is a chimeric monoclonal antibody targeting the EGFR, which has proven effective in patients with metastatic colorectal cancer (mCRC), wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS).
Determination of Cetuximab in Plasma by Liquid Chromatography-High-Resolution Mass Spectrometry Orbitrap With a Stable Labeled 13C,15N-Cetuximab Internal Standard. [2020]Cetuximab (CTX) is a chimeric IgG1 Kappa monoclonal antibody used to treat head and neck cancer and colorectal cancer. Previous clinical studies indicated that the pharmacokinetics of CTX influences patient survival. Thus, individualizing CTX treatment by measuring trough levels of the drug in plasma could have a major impact on clinical efficacy.
Topical aloe vera for the treatment of cetuximab-related acneiform rash in colorectal cancer: A case report. [2021]Colorectal cancer is one of the most common cancers in the world. Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor which provides survival benefit when combined with chemotherapy in RAS wild type metastatic colorectal cancer. Cutaneous toxicities associated with cetuximab have a significant impact on patient quality of life, treatment continuation and healthcare resource utilization.