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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: Infusions, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests azirkitug alone or with budigalimab, bevacizumab, or telisotuzumab adizutecan in adults with certain lung, head and neck, or other solid cancers. It checks side effects, doses, and how the body processes these drugs. Treatment is given through a vein for up to 2 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Provide a tumor sample before treatment, or a stored sample taken within 6 months with no treatment since then.
  • Be fully active or have only limits on hard physical activity, and be expected to live at least 3 months. Your cancer must be measurable, and blood test results must meet study rules.
  • Non-small cell lung cancer: Cancer has grown or spread despite standard treatment, including chemotherapy and PD-1/PD-L1 drugs that help the immune system fight cancer. If your cancer has gene changes that can be treated, those treatments must have failed.
  • Head and neck squamous cell cancer: Advanced or spreading cancer has worsened after platinum chemotherapy and PD-1/PD-L1 treatment for cancer that returned or spread.
  • Colorectal cancer: Cancer has worsened after the required chemotherapy, targeted drugs, TAS-102, and regorafenib. It must be microsatellite stable, meaning it does not have certain problems with DNA repair.
  • Stomach or stomach–food pipe junction cancer: Advanced or spreading cancer has worsened after at least one chemotherapy plan and immune or HER2 treatment, if needed. Pancreatic cancer: Advanced or spreading cancer has worsened after standard treatment; some mixed types and people who had Whipple surgery may qualify.
  • High-grade serous ovarian cancer: Cancer of the ovary, fallopian tube, or belly lining has worsened after standard treatment and cannot be removed by surgery. If it resists platinum treatment, you must have had no more than 5 prior treatment plans.
  • Triple-negative breast cancer: Cancer has worsened after 1 or 2 whole-body drug treatments, including a taxane drug. You must not have had immune treatment aimed at T-cell co-stimulation, a way of turning on immune cells.

Who can't join

  • For pancreatic cancer: Neuroendocrine or acinar cancer types, a blood-clotting disorder, or a history or risk of blood clots in deep veins or the lungs.
  • Major surgery within 28 days before the first dose.
  • An active disease in which the immune system attacks the body, or a weakened immune system, with limited exceptions.
  • For combination treatment: Prior PD-1/PD-L1 treatment caused severe immune-related side effects, lung tissue inflammation or scarring, or an allergic reaction. Some groups may also exclude serious heart problems or events.
  • Pregnancy.
  • Certain medicines or vaccines: Recent cancer treatment within 28 days or 5 drug half-lives, whichever is shorter; drugs targeting CCR8; live vaccines; or medicines that weaken the immune system, with limited exceptions. A half-life is the time it takes the body to clear half of a drug.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (20)

CA

IL

IN

KY

MI

MN

  • M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200 · Minneapolis, MN 55455More trials in Minneapolis

NC

NE

  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399 · Omaha, NE 68130More trials in Omaha

TX

UT

VA