A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors With Azirkitug as a Single Agent and in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

First-in-human trial of Azirkitug for lung, head & neck, and other solid tumors

NCT: NCT05005403 · Status: RECRUITING · Phase: Phase 1 · Sponsor: AbbVie · Started: 2021-11-01 · Est. Completion: 2027-07

Plain English Summary

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan is a Phase 1 clinical trial sponsored by AbbVie studying Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer, High-Grade Serous Ovarian Cancer, Pancreatic Cancer, Triple Negative Breast Cancer. This trial tests a new drug called Azirkitug, alone or with other cancer drugs, in adults with certain types of cancer. It is for patients with Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, and other specific solid tumors who have not responded to standard treatments. Participation involves receiving the study drug(s) through an IV infusion, with regular visits for monitoring and tests. Standard treatments for these cancers are available, but this trial explores a new combination therapy. The trial aims to enroll 694 participants.

Official Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of azirkitug as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Bevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)/maximum administered dose (MAD) of azirkitug will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide. Participants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with specific types of advanced or metastatic Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, or other listed solid tumors. Patients must have progressed on standard treatments and meet specific health and lab criteria. Individuals with certain active autoimmune diseases, recent major surgery, or who are pregnant cannot participate. Specific prior treatments and certain cardiac conditions may also exclude participants from combination arms. This trial is studying Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer, High-Grade Serous Ovarian Cancer, Pancreatic Cancer, Triple Negative Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the drug is (adverse events) and how the body processes it (pharmacokinetics), which helps doctors understand how to use it effectively and safely. The specific primary outcome measures are: Number of Participants with Adverse Events (AE) (Up to 2 Years); Maximum Observed Serum Concentration (Cmax) of Azirkitug (Up to 2 Years); Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug (Up to 2 Years); Terminal Elimination Half-Life (t1/2) of Azirkitug (Up to 2 Years); Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug (Up to 2 Years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial is important because it investigates a novel drug combination for difficult-to-treat cancers, potentially filling a gap for patients who have exhausted standard options. This research targets Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer, High-Grade Serous Ovarian Cancer, Pancreatic Cancer, Triple Negative Breast Cancer, where improved treatment options are needed.

Investor Insight

This Phase 1 trial of novel agents in multiple solid tumors signals a significant investment in exploring new cancer therapies, with potential for broad application if successful. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval. The large enrollment target of 694 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific drugs being tested, the potential benefits and risks, and what your daily life might be like during the trial. Be prepared for regular clinic visits for infusions, blood tests, scans, and to report any side effects. Understand that this trial may involve a higher treatment burden than standard care. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Pre Treatment biopsy or archive tissue within 6 months without intervening treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of \<= 0 or 1 and a life expectancy of \>= 3 months.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
* Laboratory values meeting criteria outlined in the protocol
* NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options.
* HSNCC - Advanced/metastatic progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting.
* Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy, TAS-102, Regorafenib and not MSI-h or MMR-deficient
* Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced/metastatic progressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicable immune checkpoint inhibitor and/or HER2 therapy
* High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection. Platinum resistant cannot have \>5 lines of prior therapy.
* Pancreatic Adenocarcinoma (PDAC) - Advanced/metastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple.
* Triple Negative Breast Cancer (TNBC) - Progressed after 1 or 2 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation

Exclusion Criteria:

* Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)/PE
* No major surgery within 28 days prior to dosing
* No active autoimmune/immunodeficiency disease with limited exceptions
* Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)/Programmed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and/or events
* Pregnancy
* Excluded medications include anticancer therapy within 5 half-live or 28 days (whichever is shorter), agent targeting Chemokine Receptor (CCR)8, live vaccines, immunosuppressive medication with limited exceptions

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05005403?

NCT05005403 is a Phase 1 INTERVENTIONAL study titled "Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan." It is currently recruiting and is sponsored by AbbVie. The trial targets enrollment of 694 participants.

What conditions does NCT05005403 study?

This trial investigates treatments for Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer, High-Grade Serous Ovarian Cancer, Pancreatic Cancer, Triple Negative Breast Cancer. The primary condition under study is Non-Small Cell Lung Cancer.

What treatments are being tested in NCT05005403?

The interventions being studied include: Azirkitug (DRUG), Budigalimab (DRUG), Bevacizumab (DRUG), Telisotuzumab Adizutecan (DRUG). Intravenous (IV) Infusion

What does Phase 1 mean for NCT05005403?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT05005403?

This trial is currently "Recruiting." It started on 2021-11-01. The estimated completion date is 2027-07.

Who is sponsoring NCT05005403?

NCT05005403 is sponsored by AbbVie. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05005403?

The trial aims to enroll 694 participants. The trial is currently recruiting and accepting new participants.

How is NCT05005403 designed?

This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT05005403?

The primary outcome measures are: Number of Participants with Adverse Events (AE) (Up to 2 Years); Maximum Observed Serum Concentration (Cmax) of Azirkitug (Up to 2 Years); Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug (Up to 2 Years); Terminal Elimination Half-Life (t1/2) of Azirkitug (Up to 2 Years); Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug (Up to 2 Years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05005403 being conducted?

This trial is being conducted at 20 sites, including Duarte, California; Irvine, California; Chicago, Illinois; Fort Wayne, Indiana and 16 more sites (United States, Canada, Israel).

Where can I find official information about NCT05005403?

The official record for NCT05005403 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05005403. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05005403 testing in simple terms?

This trial tests a new drug called Azirkitug, alone or with other cancer drugs, in adults with certain types of cancer. It is for patients with Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, and other specific solid tumors who have not responded to standard treatments.

Why is this trial significant?

This trial is important because it investigates a novel drug combination for difficult-to-treat cancers, potentially filling a gap for patients who have exhausted standard options.

What are the potential risks of participating in NCT05005403?

Common side effects may include fatigue, nausea, diarrhea, and skin reactions. More serious risks can include immune system reactions, high blood pressure, and problems with blood clotting. Specific risks depend on the combination of drugs used and individual patient health. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05005403?

Ask your doctor about the specific drugs being tested, the potential benefits and risks, and what your daily life might be like during the trial. Be prepared for regular clinic visits for infusions, blood tests, scans, and to report any side effects. Understand that this trial may involve a higher treatment burden than standard care. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05005403 signal from an investment perspective?

This Phase 1 trial of novel agents in multiple solid tumors signals a significant investment in exploring new cancer therapies, with potential for broad application if successful. This is a Phase 1 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves receiving the study drug(s) through an IV infusion, with regular visits for monitoring and tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.