QEQ278 for Cancer

Not currently recruiting at 19 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Must not be taking: Chronic steroids, Immunosuppressives

Disqualifiers: Autoimmune, Interstitial lung, Cardiac, Infections, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called QEQ278 for adults with advanced or metastatic cancers that cannot be cured by surgery or radiotherapy. The goal is to determine the treatment's safety and tolerability and to assess its effects on tumors. The trial includes two parts: identifying the right dose and then testing that dose in more participants. The study seeks participants with non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, or HPV-associated head and neck cancer who have not benefited from standard treatments. Participants must have a tumor that can be biopsied and must be willing to undergo these biopsies during the study. As a Phase 1 trial, this research focuses on understanding 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 protocol does not specify if you need to stop taking your current medications. However, if you are on systemic chronic steroid therapy or any immunosuppressive therapy, you may need to stop these at least 7 days before starting the study treatment.

Is there any evidence suggesting that QEQ278 is likely to be safe for humans?

Research has shown that QEQ278 has been generally safe in early studies, meaning most participants haven't experienced serious problems. However, drugs like QEQ278, which target cancer at the molecular level, can sometimes cause serious side effects that vary among individuals. Although the treatment remains under investigation, researchers closely monitor it to ensure safety. Prospective participants should consider these factors and discuss them with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about QEQ278 because it represents a novel approach in cancer treatment. Unlike current therapies that often target cancer cells broadly, QEQ278 is designed to target specific pathways involved in cancer cell growth. This precision could potentially reduce side effects and improve effectiveness. Additionally, QEQ278's unique mechanism may offer a new option for patients who haven't responded well to traditional treatments like chemotherapy or radiation.

What evidence suggests that QEQ278 might be an effective treatment for cancer?

Research has shown that QEQ278, a new drug, is being tested for effectiveness against difficult-to-treat cancers, such as lung and esophageal cancer. In early studies with patients who have advanced solid tumors, researchers observed some anti-tumor activity, indicating the drug might shrink tumors or slow their growth. More than half of the participants experienced side effects, though only a few had severe reactions. These results are promising but remain in the early stages, as researchers focus on understanding the drug's safety and mechanism of action. This trial, which includes a dose escalation phase and a dose expansion phase, aims to determine if QEQ278 could become a useful new option for cancer treatment. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with advanced cancers like non-small cell lung, renal cell, esophageal squamous cell carcinoma, or HPV-related head and neck cancer. Participants must have measurable disease, be unresponsive to standard treatments or ineligible for them, and willing to undergo tumor biopsies. Exclusions include those with tuberculosis history, poor bone marrow function, serious infections including COVID-19, significant cardiac issues or a history of severe reactions to anti-PD-1 therapy.

Inclusion Criteria

I have been diagnosed with esophageal squamous cell carcinoma.

I am willing and able to have a tumor biopsy as per my hospital's rules.

My cancer in the head or neck is linked to HPV.

Exclusion Criteria

I have never had severe lung inflammation.

I do not have any serious uncontrolled infections.

I have heart problems or risk factors for heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients with various cancers are treated with QEQ278 until the maximum tolerated dose is reached or a lower recommended dose is established

24 weeks

Regular visits for dose adjustments and monitoring

Dose Expansion

After establishing the maximum tolerated dose, further patients are treated to assess safety and efficacy

24 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 months

What Are the Treatments Tested in This Trial?

Interventions

• QEQ278

Trial Overview The trial is testing the safety and effects of QEQ278 when given intravenously to patients with certain advanced solid tumors. It will assess how the body processes the drug (pharmacokinetics), its impact on the body (pharmacodynamics), tolerability at different doses and preliminary effectiveness in shrinking tumors.

How Is the Trial Designed?

Group I: Part 2: Dose expansion Experimental Treatment 1 Intervention

Dose expansion with QEQ278 single agent

Group II: Part 1: Dose escalation Experimental Treatment 1 Intervention

Dose escalation with QEQ278 single agent

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.

The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. Wang, Z., Yang, X., Wang, J., et al.[2020]

The ADEStrata approach, developed in this study, allows for the stratification of tumor mutations based on adverse drug events (ADEs), specifically focusing on musculoskeletal adverse events in breast cancer patients treated with aromatase inhibitors, using data from 212 patients.

By prioritizing somatic variants linked to ADEs, the study found that this method can identify high-risk patients who may experience poor outcomes, suggesting that it could help tailor cancer therapies to improve patient safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Drug Event-based Stratification of Tumor Mutations: A Case Study of Breast Cancer Patients Receiving Aromatase Inhibitors. Wang, C., Zimmermann, MT., Prodduturi, N., et al.[2018]

The number of post-authorization safety and effectiveness studies (PASSs/PAESs) for oncology drugs has significantly increased, from just 1 study between 2006-2010 to 47 studies from 2016-2020, indicating a growing emphasis on real-world evidence for drug safety and effectiveness.

Most of these studies (64.1%) focused on safety/risk assessment, particularly regarding adverse events, while effectiveness studies primarily aimed at measuring overall survival, highlighting the need for more comparative analyses in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulator-Requested Non-Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review. Zhang, X., Chen, L., Bracco, OL., et al.[2022]

Osimertinib significantly improves progression-free survival (PFS) in patients with metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation, showing a median PFS of 10.1 months compared to 4.4 months with chemotherapy in a trial of 419 patients.

The safety profile of osimertinib is favorable compared to other EGFR tyrosine kinase inhibitors and chemotherapy, with common side effects including diarrhea and rash, making it a viable treatment option for patients who have progressed on previous therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation. Odogwu, L., Mathieu, L., Goldberg, KB., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05462873

NCT05462873 | A Study to Investigate the Safety and ... This study is an open-label, phase I/Ib, multi-center study of QEQ278 as a single agent, consisting of a dose escalation part followed by a dose expansion part.

2. researchgate.net researchgate.net/publication/396806233_Abstract_B002_A_first-in-human_first-in-class_phase_1_trial_of_QEQ278_in_patients_with_advanced_solid_tumors

A first-in-human, first-in-class, phase 1 trial of QEQ278 in ... Treatment-related AEs (TRAEs) were reported in 16 (53.3%) pts, with 7 (23.3%) pts experiencing grade ≥3 TRAEs. The most commonly reported TRAEs ...

3. withpower.com withpower.com/trial/phase-1-squamous-cell-carcinoma-of-head-and-neck-9-2022-57857

QEQ278 for Cancer · Info for Participants This trial is testing a new drug called QEQ278 in adults with advanced cancers that are hard to treat. Researchers aim to find out if the drug is safe and if ...

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05462873/

Trial | NCT05462873 To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with ...

5. prnewswire.com prnewswire.com/news-releases/esophageal-squamous-cell-carcinoma-pipeline-looks-promising-as-45-companies-working-in-the-domain-assesses-delveinsight-301658291.html

Esophageal Squamous Cell Carcinoma Pipeline Looks ... Tislelizumab plus chemotherapy demonstrated a median OS of 17.2 months (CI, 15.8-20.1 months) versus 10.6 months (CI, 9.3-12.1 months) in ...

6. aacrjournals.org aacrjournals.org/mct/article/24/10_Supplement/B002/766263/Abstract-B002-A-first-in-human-first-in-class

Abstract B002: A first-in-human, first-in-class, phase 1 trial of ... Conclusions: Early clinical data of QEQ278 monotherapy reported an acceptable safety profile in pts with advanced solid malignancies. Further ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=ee00bc89-9051-4561-ab29-cf72cc6f40bd

QEQ278 / Novartis Clinical • First-in-human • Metastases • P1 data • Esophageal Cancer ... Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors ...