What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as EGFR inhibitors like cetuximab, often cause side effects including skin rash, diarrhea, and hypomagnesemia. Chemotherapy agents like cisplatin and doxorubicin can lead to nausea, vomiting, nephrotoxicity, and cardiotoxicity. Immune checkpoint inhibitors may result in immune-related adverse events such as pneumonitis, colitis, and dermatitis.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors, often focusing on targeted therapies and immunotherapies. For instance, pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors approved for various solid tumors, including melanoma and non-small cell lung cancer. Additionally, vemurafenib (Zelboraf) targets BRAF mutations in melanoma. Investigational drugs like ONC201, which is being studied for H3 K27M-mutant gliomas, show promise despite their mechanisms being not fully understood. These approvals and ongoing studies reflect a trend towards personalized medicine and targeted treatments in oncology.

What other types of research exist?

Promising novel alternatives to QTX3034 for solid tumor patients include: <ol> <li>TAK-285: A non-Pgp substrate HER2/EGFR kinase inhibitor showing strong antitumor activity in brain metastasis models.</li> <li></li> </ol> PQR309: A dual PI3K/mTOR pathway inhibitor with demonstrated anti-glioma activity, especially when combined with AKT inhibition. 3. LQFM030: Demonstrated reduction in tumor cell proliferation and VEGF levels in preclinical models, indicating potential for solid tumors.

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Monoclonal Antibodies

QTX3034 + Cetuximab for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Quanta Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic

Must not have

Significant cardiovascular disease

Active brain metastases or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed here but generally, drugs like QTX3034 and cetuximab can cause skin reactions, infusion-related discomfort, fatigue, low blood counts leading to increased infection risk, and possibly liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is advanced or has spread, and tests show a KRAS G12D mutation.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I have active brain tumors or cancer in the lining of my brain.

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I have been treated with a KRAS inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with Dose Limiting Toxicities (DLTs)

Number of participants with Treatment-emergent Adverse Events (TEAEs)

Secondary study objectives

Duration of response (DOR)

Objective response rate (ORR)

QTX3034 pharmacokinetic parameters in plasma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as those aimed at specific genetic mutations like KRAS G12D, inhibit cancer growth by interfering with specific molecules involved in tumor growth and progression. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most effective treatment with the least side effects, and in developing personalized treatment plans based on the tumor's specific genetic profile.

Quantifying Risk Pathway Crosstalk Mediated by miRNA to Screen Precision drugs for Breast Cancer Patients.